Prometrium

(progesterone)

ApprovedSmall molecule

Progesterone is a hormone used to help regulate menstrual cycles, support pregnancy, and treat symptoms of menopause. It can also be used to prevent overgrowth of the uterine lining in women taking estrogen therapy.[2] Prometrium is currently approved and in use across 56 indications[4].[1]

Prometrium is one of 1016 small molecule programs targeting Premature Birth. It is currently in Approved.

Indications

213

Total Trials

Active Trials

1,015

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Premature BirthApproved

ContraceptionApproved

Small for Gestational AgeActive, not recruiting

Endometrial PolypActive, not recruiting

Methamphetamine DependenceApproved

Nicotine DependenceApproved

Paroxysmal Familial Ventricular FibrillationApproved

AdenomyosisActive, not recruiting

Depressive DisorderApproved

Female InfertilityApproved

Premature BirthApproved

Approved

ContraceptionApproved

Approved

Small for Gestational AgePreclinical

Active, not recruiting

Endometrial PolypPhase 3

Active, not recruiting

Methamphetamine DependenceApproved

Approved

Nicotine DependenceApproved

Approved

Paroxysmal Familial Ventricular FibrillationApproved

Approved

AdenomyosisPhase 3

Active, not recruiting

Depressive DisorderApproved

Approved

Female InfertilityApproved

Approved

Showing 10 of 55 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Prometrium

Halaven

38 3

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 4

MS Contin

Merck & Co.

Preclinical

2 5

Zinecard

CChildren's Oncology Group

Preclinical

2 6

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 7

Chirocaine

PPurdue Pharma LP

Preclinical

1 8

Avastin

Roche

Preclinical

4 9

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 10

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Progesterone

NCT06463652

N/ANot yet recruiting

Pregnancy

NCT03637062

Post-ApprovalRecruiting

Frozen Embryo Transfer

NCT06875752

Q1 2027

Post-ApprovalRecruiting

Bone Health

NCT05704036

Phase 2Recruiting

Hormone Therapy

NCT06807580

N/ANot yet recruiting

Pregnancy

NCT07425990

Clinical

Trials by Indication[1]

Progesterone46 trials

Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial

Terminated·SStanford University·Phase 2/3·NCT00946088·7 enrolled

Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect

Withdrawn·MMclean Hospital·N/A·NCT01589081

Progesterone for Smoking Relapse Prevention Following Delivery

Completed·YYale University·Phase 2·NCT01972464·41 enrolled

Show 43 more trials

Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved(Frozen)-Thawed Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone.

Completed·UUniversitair Ziekenhuis Brussel·Phase 4·NCT02032797·300 enrolled

Progesterone Microspheres Pharmacokinetic - Pharmacodynamic (PK-PD) Study

Completed·UUnknown Sponsor·Phase 1·NCT01176175·48 enrolled

Effect of Progesterone Administration on Severely Head Injured Patients

Not yet recruiting·—·Phase 1·NCT06631547·50 enrolled

Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert

Not yet recruiting·DDaré Bioscience, Inc.·Phase 1·NCT06668896·60 enrolled

Impact of Different Doses and Routes of Exogenous Progesterone Administration on Endometrial Receptivity Parameters

Completed·IInstituto Valenciano de Infertilidad, IVI VALENCIA·Phase 4·NCT04499131·109 enrolled

Progesterone & Postpartum Relapse to Smoking

Completed·UUniversity of Minnesota·N/A·NCT01798394·46 enrolled

Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)

Completed· Ferring logo

Ferring·Phase 4·NCT01225835·124 enrolled

Progesterone and Atomoxetine for Cocaine Cessation

Withdrawn·UUniversity of Minnesota·N/A·NCT01741376

Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Completed·YYale University·Phase 2/3·NCT02187224·13 enrolled

Optimal Length of Progesterone Supplementation Before the Transfer of Cryopreserved (Frozen)-Thawed Day 3 Embryos in an Artificial Cycle With Exogenous Estrogen and Progesterone

Completed·UUniversitair Ziekenhuis Brussel·Phase 4·NCT01940653·300 enrolled

Role of Low Dose Injectable Progesterone in Triggering Ovulation

Recruiting·—·N/A·NCT06928844·120 enrolled

Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening

Completed·IIndiana University·Phase 2·NCT01929083·19 enrolled

Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

Terminated·UUniversity of Virginia·N/A·NCT01428193·4 enrolled

Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle

Completed·—·N/A·NCT04846218·100 enrolled

Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix

Not yet recruiting·NNational Hospital of Obstetrics and Gynecology·N/A·NCT07372495·260 enrolled

Progesterone for Cannabis Withdrawal

Completed·MMedical University of South Carolina·Phase 1·NCT03430050·8 enrolled

Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone

Unknown status·UUniversity of Virginia·Phase 1·NCT01428089·40 enrolled

Randomized Trial of Maternal Progesterone Therapy

Completed·—·Phase 2·NCT02133573·102 enrolled

Assessment of the Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition

Unknown status·UUniversity of Virginia·N/A·NCT01425541·60 enrolled

Progesterone and Aminophylline for the Prevention of Preterm Labour

Unknown status·SSt Stephens Aids Trust·Phase 1·NCT03152942·70 enrolled

Endometrial Effects of Daily Progesterone s.c. 25 and 50 Mg Aqueous Formulation to Female Healthy Volunteers

Completed·IIBSA Institut Biochimique SA·Phase 1·NCT00377923·24 enrolled

Administration of Vaginal and Rectal Progesterone During FET Cycles

Completed·TThor Haahr··NCT03470610·277 enrolled

Effect of Progesterone Therapy on Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler

Unknown status·MMinia University·Phase 1·NCT04426487·200 enrolled

Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles

Terminated·AAndros Day Surgery Clinic·Phase 4·NCT03181685·60 enrolled

Progesterone and Cervical Pessary in Twins

Unknown status·MMario Henrique Burlacchini de Carvalho·Phase 2/3·NCT03058536·312 enrolled

Luteal Phase Progesterone in IUI and Gonadotropin Cycles

Completed·UUniversity of Alberta·Phase 3·NCT01941875·300 enrolled

Progesterone as Luteal Support in Frozen IVF Natural Cycles

Recruiting·VVastra Gotaland Region·Phase 4·NCT04725864·1,800 enrolled

Pessary Versus Cerclage With or Without Progesterone in Twins

Terminated·MMỹ Đức Hospital·N/A·NCT03863613·219 enrolled

Vaginal Progesterone Improves Clinical Outcomes of RIF Patients

Unknown status·NNanjing University·N/A·NCT06005207·152 enrolled

Progesterone Augmentation of Nicotine Replacement Therapy Study

Completed·YYale University·Phase 4·NCT02685072·64 enrolled

Subcutaneous Progesterone Versus Vaginal Progesterone for Endometrial Preparation in Fresh Donated Oocytes Recipients

Completed·IInstituto Bernabeu·Phase 4·NCT02363127·120 enrolled

Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Completed·UUniversity of Oklahoma·N/A·NCT00579553·174 enrolled

Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies

Recruiting·MMỹ Đức Hospital·N/A·NCT06463652·328 enrolled

Pessary Versus Progesterone in Singletons

Unknown status·MMỹ Đức Hospital·N/A·NCT04300322·804 enrolled

Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles

Withdrawn·—·Phase 4·NCT02772120

Vaginal Progesterone in Twin With Short Cervix

Completed·—·Phase 3·NCT02697331·144 enrolled

The Vaginal Progesterone and Cerclage

Completed·—·Phase 2·NCT02846909·242 enrolled

Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II

Completed·MMedical University of Vienna·Phase 2·NCT00247169·40 enrolled

A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.

Unknown status·NNordica Fertility Clinic·Phase 4·NCT00708539·2,686 enrolled

Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition

Terminated·UUniversity of Virginia·N/A·NCT01428245·3 enrolled

Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

Completed·UUniversity of Virginia·N/A·NCT01427595·25 enrolled

Progesterone for Postpartum Cocaine Relapse

Completed·YYale University·N/A·NCT01249274·50 enrolled

Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls

Completed·UUniversity of Virginia·Phase 1·NCT01773772·14 enrolled

Pregnancy12 trials

Does Hormonal Luteal Support After Intra-uterine Insemination (IUI) Increase the Pregnancy Rate?

Terminated·UUniversity Hospital, Gasthuisberg·N/A·NCT00700492·82 enrolled

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

Completed·OOrganon and Co··NCT00703014·541 enrolled

Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes

Completed·UUniversitair Ziekenhuis Brussel·Phase 1/2·NCT01147770·200 enrolled

Show 9 more trials

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)

Completed·OOrganon and Co··NCT00702624·113 enrolled

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)

Completed·OOrganon and Co··NCT00702234·268 enrolled

A Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle

Unknown status·NNanjing University·Phase 2·NCT04938011·900 enrolled

FET-LET-2x2: Clinical Pregnancy Rates After Frozen Embryo Transfer in Natural and Modified Natural Cycles

Not yet recruiting·UUniversity of Novi Sad·N/A·NCT07425990·120 enrolled

Low Dose Prednisone Therapy in Women With Recurrent Pregnancy Loss

Unknown status·SSoroka University Medical Center·Phase 2/3·NCT04558268·242 enrolled

Verify the Safety and Effectiveness of the Cerclage Pessary in Prevention and Treatment of High-risk Preterm Pregnancy

Not yet recruiting·QQH Medical Technology Ltd.·N/A·NCT03637062·300 enrolled

Pregnancy Outcome of Women Using Low Molecular Weight Heparin Before Frozen-thawed Embryo Transfer

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT03120715·342 enrolled

the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes

Completed·—··NCT04733235·205 enrolled

Pharmacokinetics of Progesterone in Pregnancy

Completed·TThomas Jefferson University·Phase 1·NCT03340701·6 enrolled

Luteal Phase Support9 trials

Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

Completed·—·Phase 4·NCT05286554·75 enrolled

A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01081652·238 enrolled

GnRH Agonist for Luteal Phase Support.

Unknown status·SShaare Zedek Medical Center·N/A·NCT05484193·150 enrolled

Show 6 more trials

Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF)

Completed·IIBSA Institut Biochimique SA·Phase 3·NCT00827983·683 enrolled

Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support

Completed·UUniversita di Verona·N/A·NCT03734770·149 enrolled

Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment

Recruiting·UUMC Utrecht·Phase 4·NCT05080569·1,008 enrolled

Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

Completed·RRoberta Venturella·Phase 4·NCT02316626·246 enrolled

Comparison of the Effect of Subcutaneous Progesterone and Vaginal Progesterone for Luteal Phase Support

Completed·—·N/A·NCT05276531·146 enrolled

Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles

Unknown status·MMemorial Sisli Hospital, Istanbul·Phase 4·NCT04124913·140 enrolled

Frozen Embryo Transfer8 trials

The Outcome of Two Protocols Used to Prepare Endometrium for Frozen Embryo Transfer

Completed·RRahem Fertility Center·Phase 4·NCT04507022·112 enrolled

the Effects of GnRHa Add up to Routine Luteal Phase Support on Frozen Embryo Implantation in Frozen Embryo Transfer .

Unknown status·CChong Qing Reproducive and Genetic Institute·Phase 4·NCT02655146·700 enrolled

Estradiol and Progesterone Levels Following Frozen Embryo Transfer

Completed·—·Phase 4·NCT04997525·305 enrolled

Show 5 more trials

Rescue Progesterone Supplementation During Frozen Embryo Transfer

Suspended·CClinique Ovo·Phase 2·NCT05555121·150 enrolled

Is There a Need for Luteal Support in Modified Natural Cycle Frozen Embryo Transfer Cycles

Recruiting·DDunamenti REK Istenhegyi IVF Center·Phase 4·NCT06875752·180 enrolled

MIcronized PROgesterone in Frozen Embryo Transfer Cycles

Recruiting·FFundación Santiago Dexeus Font·Phase 3·NCT05899010·1,020 enrolled

Prolutex in Frozen Embryo Transfer Cycles At the Blastocyst Stage (PROGEX)

Completed·IIBSA Institut Biochimique SA·Phase 2·NCT03701490·213 enrolled

Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles

Completed·—·N/A·NCT05189145·600 enrolled

Preterm Labor7 trials

Vaginal Progesterone Supplementation in the Management of Preterm Labor

Completed·—·N/A·NCT03202836·90 enrolled

Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

Completed·MMohamed Sayed Abdelhafez·Phase 4·NCT02338830·182 enrolled

Vaginal Progesterone 400mg v.s 200mg for Prevention of Preterm Labor in Twin Pregnancies

Completed·—·Phase 4·NCT04748562·100 enrolled

Show 4 more trials

Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation

Unknown status·—·N/A·NCT03781674·200 enrolled

Oral Versus Parental Progesterone in the Management of Preterm Labor

Completed·—·Phase 4·NCT03343795·80 enrolled

17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

Unknown status·MMeir Medical Center·Phase 3·NCT00809939·800 enrolled

Different Types of Progesterone in the Prevention of Preterm Labor

Unknown status·—·Phase 2·NCT03537287·140 enrolled

79 more indications

Preterm Birth7 trials

Vaginal Progesterone for the Prevention of Preterm Birth in Twins

Withdrawn·CChiu Yee Liona Poon·Phase 3·NCT03540225

The Use of Progesterone to Reduce Preterm Birth

Completed·UUniversity of Mississippi Medical Center·N/A·NCT00830765·144 enrolled

Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT02970552·140 enrolled

Show 4 more trials

Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth

Not yet recruiting·—·N/A·NCT07415070·1,000 enrolled

Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

Completed·TThomas Jefferson University·Phase 4·NCT02913495·210 enrolled

Natural Progesterone and Preterm Birth in Twins

Completed·IInstituto Valenciano de Infertilidad, IVI VALENCIA·Phase 3·NCT00480402·290 enrolled

Prolonged Progesterone to Prevent Preterm Birth From IVF - ET

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 4·NCT05787509·100 enrolled

Preterm Delivery5 trials

Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

Terminated·Bbegoña Martinez de Tejada·Phase 3·NCT00536003·384 enrolled

Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies

Completed·UUniversity of Sao Paulo·Phase 4·NCT01031017·390 enrolled

Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery

Completed·GGrünenthal GmbH·Phase 2·NCT02225353·271 enrolled

Show 2 more trials

Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies?

Completed·RRigshospitalet, Denmark·Phase 2·NCT00329914·677 enrolled

Preterm Delivery Prevention in Twins With Progesterone

Unknown status·UUniversidad del Desarrollo·Phase 4·NCT01927029·213 enrolled

Embryo Transfer4 trials

Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles

Completed·—·Phase 4·NCT03619707·157 enrolled

Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

Completed·OOrganon and Co··NCT00702273·344 enrolled

Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)

Completed·OOrganon and Co··NCT00702546·102 enrolled

Show 1 more trial

Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist

Completed·—·Phase 3·NCT02736032·310 enrolled

Ovarian Stimulation4 trials

To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)

Completed·OOrganon and Co·Phase 3·NCT00702845·397 enrolled

A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)

Completed·OOrganon and Co·Phase 3·NCT00696800·1,509 enrolled

To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference

Completed· Changchun GeneScience Pharmaceutical Co., Ltd. logo

Changchun GeneScience Pharmaceutical Co., Ltd.·Phase 3·NCT06091436·176 enrolled

Show 1 more trial

Efficacy of Micronized Natural Progesterone Vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.

Recruiting·IInstituto Bernabeu·Phase 4·NCT05954962·150 enrolled

Cervical Cerclage4 trials

Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix

Unknown status·—·N/A·NCT03781466·300 enrolled

Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix

Completed·TThomas Jefferson University·Phase 4·NCT03251729·93 enrolled

Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage

Completed·HHina Mukhtar·N/A·NCT07307092·820 enrolled

Show 1 more trial

Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM

Unknown status·MMohamed Sayed Abdelhafez·Phase 4·NCT02673359·220 enrolled

Treatment3 trials

Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC

Recruiting·WWest China Second University Hospital·Phase 2/3·NCT03463252·224 enrolled

Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?

Completed·TThe Alfred·Phase 2·NCT00206544·51 enrolled

A Treatment Study for Premenstrual Syndrome (PMS)

Completed·NNational Institute of Mental Health (NIMH)·Phase 1·NCT00001259·60 enrolled

Postmenopausal Women3 trials

Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

Completed·EEstetra·Phase 3·NCT04209543·1,570 enrolled

Postmenopausal Women Estrogen and Progesterone Infusion

Completed·MMassachusetts General Hospital·Phase 1/2·NCT00455741·20 enrolled

Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women

Completed·IIntira Sriprasert·Phase 3·NCT02224313·20 enrolled

Controlled Ovarian Stimulation2 trials

Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)

Completed·OOrganon and Co·Phase 3·NCT00696878·682 enrolled

An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029)

Withdrawn·OOrganon and Co·Phase 3·NCT01599494

Women2 trials

Lutropin Alfa in Women at Risk of Poor Response

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01112358·58 enrolled

Reducing the Risk of Drug-Induced QT Interval Lengthening in Women

Completed·IIndiana University·Phase 4·NCT03834883·27 enrolled

Bone Health2 trials

Estrogen Supplementation and Bone Health in Women With CF

Recruiting·JJohns Hopkins University·Phase 4·NCT05704036·75 enrolled

Rhythmic Estradiol and Bone Health

Completed·—·Phase 4·NCT05903820·48 enrolled

Miscarriage2 trials

Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

Completed·WWoman's Health University Hospital, Egypt·Phase 4·NCT01670929·700 enrolled

Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial

Completed·SSir Mortimer B. Davis - Jewish General Hospital·Phase 2·NCT02145767·850 enrolled

Premature Birth2 trials

Prediction and Prevention of Twin Premature Birth 2021

Unknown status·CCaixia Liu·Phase 4·NCT05061641·300 enrolled

Cervical Pessary vs. Vaginal Progesterone for Preventing Premature Birth in IVF Twin Pregnancies

Completed·VVietnam National University·N/A·NCT02623881·300 enrolled

Brain Injury2 trials

Progesterone for the Treatment of Traumatic Brain Injury III

Terminated·DDavid Wright·Phase 3·NCT00822900·882 enrolled

Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

Completed·BBHR Pharma, LLC·Phase 3·NCT01143064·1,195 enrolled

Concentration2 trials

Compare the Difference of P4 Concentration in Serum and Endometrium After Vaginal and IM P Administration

Completed·PPeking Union Medical College Hospital·Phase 1/2·NCT01057511·51 enrolled

Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen

Terminated·SSt. Louis University·Phase 2·NCT04534881·5 enrolled

Hormone Therapy2 trials

Progesterone in Gender Affirming Hormone Therapy Study

Recruiting·EEmory University·Phase 2·NCT06807580·40 enrolled

Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

Unknown status·UUniversity Hospital of North Norway·Phase 4·NCT01123538·40 enrolled

Preeclampsia2 trials

PP13 and Doppler Study to Predict Preeclampsia

Unknown status·—·Phase 2/3·NCT00928213·1,000 enrolled

Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

Terminated·JJohn Uckele·N/A·NCT00719537·3 enrolled

GnRH Antagonist2 trials

Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response

Completed·SShangHai Ji Ai Genetics & IVF Institute·Phase 3·NCT04414761·784 enrolled

Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders

Completed·—·Phase 3·NCT04537078·90 enrolled

Age2 trials

Cerclage for Twins With Short Cervix

Withdrawn·PPediatrix·Phase 2/3·NCT03077633

LATe Cerclage in High-risk Pregnancies (LATCH)

Recruiting·TThomas Jefferson University·N/A·NCT06036446·329 enrolled

COVID-192 trials

Progesterone for the Treatment of COVID-19 in Hospitalized Men

Completed·SSara Ghandehari·Phase 1·NCT04365127·40 enrolled

Estradiol and Progesterone in Hospitalized COVID-19 Patients

Terminated·TTulane University·Phase 2·NCT04865029·10 enrolled

Pregnant Women2 trials

Comparison in Cervical Length and Prolongation of Gestation Age on Vaginal Progesterone Administration to Pregnant Women After the Acute Phase of Threatened Preterm Birth

Active, not recruiting·—·N/A·NCT06975943·48 enrolled

Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

Unknown status·EEwha Womans University Mokdong Hospital·Phase 3·NCT02304237·360 enrolled

Placenta Previa2 trials

Progesterone in Patients With Placenta Previa

Unknown status·—·Phase 2·NCT03633175·74 enrolled

Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa

Unknown status·—·N/A·NCT03779451·400 enrolled

Randomized Controlled Trial2 trials

Randomized Controlled Trial of Vaginal Progesterone in Women With Threatened Preterm Labor

Terminated·UUniversity of Calgary·Phase 4·NCT01286246·34 enrolled

Cervical Pessary vs Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial

Unknown status·HHillel Yaffe Medical Center·Phase 2/3·NCT02470676·430 enrolled

In Vitro Fertilization (IVF)2 trials

Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)

Completed·—·Phase 4·NCT00656201·468 enrolled

Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)

Completed·IIBSA Institut Biochimique SA·Phase 3·NCT00828191·800 enrolled

Heart Disease1 trial

Relationship Between the Menstrual Cycle and Heart Disease in Women

Completed·OOregon Health and Science University·N/A·NCT01546454·5 enrolled

Maintenance Treatment1 trial

Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)

Completed·HHospital Clinic of Barcelona·Phase 4·NCT00646802·265 enrolled

Polycystic Ovarian Syndrome1 trial

Progesterone Primed Ovarian Stimulation Versus GnRH Antagonist Protocols in Women With Polycystic Ovarian Syndrome

Completed·—··NCT06812559·100 enrolled

Menopausal Women1 trial

Efficacy Study of Progesterone Tablet in Post-menopausal Women

Completed·IIBSA Institut Biochimique SA·Phase 2·NCT02841137·80 enrolled

Marijuana1 trial

Hormones and Reduction in Co-users of Marijuana and Nicotine

Completed·UUniversity of Minnesota·N/A·NCT02579421·58 enrolled

Endometrial Cancer1 trial

Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer

Unknown status·SShanghai First Maternity and Infant Hospital·Phase 1·NCT04046185·60 enrolled

Estrogen1 trial

Women's Angiographic Vitamin and Estrogen Trial (WAVE)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000555

Postpartum Depression1 trial

Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT01762943·36 enrolled

Cognition1 trial

Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women

Completed·MMax-Planck-Institute of Psychiatry·Phase 4·NCT00530582·10 enrolled

Mood Disorder1 trial

The Role of Hormones in Postpartum Mood Disorders

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00001481·74 enrolled

Phase II1 trial

Prediction of Metaphase II Oocytes According to Different Levels of Serum AMH in Poor Responders Using the Antagonist Protocol

Unknown status·—·N/A·NCT03484611·179 enrolled

Unstable Angina1 trial

Postmenopausal Hormone Therapy in Unstable Angina

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000601

Concussion1 trial

Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

Completed·WWake Forest University Health Sciences·Phase 4·NCT01809639·25 enrolled

Hormone Replacement Therapy1 trial

Effects of Hormone Replacement Therapy on Inflammation and Stiffening of Artery Walls

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00005108·25 enrolled

Diagnosis1 trial

Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist

Completed·UUniversitair Ziekenhuis Brussel·Phase 4·NCT01888744·120 enrolled

Luteal Phase Deficiency1 trial

Progesterone in Luteal Phase Deficiency

Withdrawn·IIBSA Institut Biochimique SA·Phase 3·NCT02950948

Cannabis Use1 trial

Impact of Progesterone on Stress Reactivity and Cannabis Use

Completed·MMedical University of South Carolina·Phase 2·NCT03729869·148 enrolled

Atherosclerosis1 trial

Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women

Completed·—·Phase 2·NCT03018366·29 enrolled

Memory1 trial

Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00006399·45 enrolled

Uterine Fibroid1 trial

Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

Completed· AbbVie logo

AbbVie·Phase 2·NCT01441635·271 enrolled

Trial1 trial

PREGNANT Short Cervix Trial

Completed·JJuniper Pharmaceuticals, Inc.·Phase 3·NCT00615550·465 enrolled

Drug1 trial

Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening

Completed·IIndiana University·Phase 4·NCT04675788·73 enrolled

Torsades de Pointes1 trial

Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes

Completed·IIndiana University·Phase 4·NCT02513940·14 enrolled

Tolerance1 trial

Sex Hormones and Orthostatic Tolerance

Completed·YYale University·Phase 2·NCT01153581·109 enrolled

Cocaine Dependence1 trial

Progesterone for the Treatment of Cocaine Dependence - 1

Completed·UUniversity of Minnesota·N/A·NCT00218257·96 enrolled

Safety and Efficacy1 trial

A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms

Completed·TTherapeuticsMD·Phase 3·NCT01942668·1,845 enrolled

Smoking Cessation1 trial

Sex Differences, Hormones & Smoking Cessation

Completed·UUniversity of Minnesota·N/A·NCT01744574·216 enrolled

Methamphetamine Use1 trial

PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)

Recruiting·UUniversity of Utah·Phase 1·NCT05128071·40 enrolled

Function1 trial

Sex Steroids, Sleep, and Metabolic Dysfunction in Women

Completed·WWashington University School of Medicine·N/A·NCT00805207·61 enrolled

Smoking Behavior1 trial

Effect of Progesterone on Smoking Behavior in Male and Female Smokers

Completed·YYale University·Phase 1·NCT00271206·65 enrolled

Pre-Term1 trial

Detection of Preterm Labour by Cervical Length

Unknown status·—·Phase 1·NCT04104984·966 enrolled

Mortality1 trial

A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT06572761·350 enrolled

Menstrual Cycle1 trial

Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women

Completed·UUniversity of Pennsylvania·N/A·NCT00676026·8 enrolled

Efficacy and Safety1 trial

A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07340827·333 enrolled

Injury1 trial

Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

Terminated·ZZeynep Kamil Maternity and Pediatric Research and Training Hospital·N/A·NCT02492451·118 enrolled

Atrophy1 trial

Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy

Withdrawn·MMount Sinai Hospital, Canada·Phase 2·NCT02460302

Outcome1 trial

The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes

Unknown status·ZZekai Tahir Burak Women's Health Research and Education Hospital·N/A·NCT02114645·100 enrolled

Clinical Trial1 trial

Clinical Trial Comparing Endometrial Transformation With Subcutaneous Progesterone Versus Intramuscular Progesterone

Completed·IIVI Barcelona·Phase 4·NCT02567552·24 enrolled

Lip1 trial

Lipoic Acid Supplementation in IVF

Completed·LLo.Li.Pharma s.r.l·Phase 4·NCT03023514·172 enrolled

IVF1 trial

Luteal Supplementation With Rec-LH After GnRH-agonist Triggering in In Vitro (IVF)

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 4·NCT00954811·40 enrolled

Vasomotor Symptoms1 trial

Study of Progesterone in Treatment of Vasomotor Symptoms

Terminated·BBHR Pharma, LLC·Phase 3·NCT03202186·55 enrolled

Endometrial Polyp1 trial

Endometrial Polyps Regression With Progesterone Therapy

Unknown status·UUniversity Magna Graecia·Phase 3·NCT03309709·90 enrolled

Menstrual disorder1 trial

Clinical and Basic Researches Related to ZhenQi Buxue Oral Liquid in Treating Menstrual Disorders

Unknown status·PPeking Union Medical College Hospital·N/A·NCT05312190·330 enrolled

Small for gestational age1 trial

Omega 3 Plus Vaginal Progesterone on Birth Weight of Constitutionally Small for Gestational Age Fetuses

Completed·—·N/A·NCT04161989·80 enrolled

Menopause1 trial

The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood

Terminated·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT03003949·82 enrolled

Irritability1 trial

Estrogen Variability and Irritability During the Menopause Transition

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT05388656·40 enrolled

Sex Differences1 trial

Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues

Completed·YYale University·Phase 1·NCT00585520·60 enrolled

Stroke1 trial

Progesterone in the Treatment of Acute Hemorrhagic Stroke

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04143880·184 enrolled

ESS1 trial

Perimenopausal Effects of Estradiol on Reward Responsiveness

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT02255175·64 enrolled

Obesity1 trial

Estrogen Sensitivity and Ovulatory Dysfunction in Obesity

Completed·UUniversity of Colorado, Denver·N/A·NCT01381016·30 enrolled

Endometrial1 trial

Clinical Study on Endometrial Receptivity

Unknown status·PPeking Union Medical College Hospital·Phase 1·NCT03687021·35 enrolled

Mood1 trial

The Effects of Reproductive Hormones on Mood and Behavior

Completed·NNational Institute of Mental Health (NIMH)·Phase 1/2·NCT00001322·100 enrolled

Hematoma1 trial

Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

Completed·AAzienda USL Ferrara·Phase 4·NCT02601898·54 enrolled

Adenomyosis1 trial

Nintedanib for Improving Reproductive Outcomes in Adenomyosis

Not yet recruiting·SSun Yat-sen University·Phase 3·NCT07162961·328 enrolled

Depression1 trial

Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression

Recruiting·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT06610305·75 enrolled

Abortion1 trial

Progesterone Supplementation in Threatened Abortion

Completed·TTanta University·Phase 4·NCT03930212·190 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

PROGESTERONE

NDA NDA009238

Jan 1, 1982

PROGESTERONE

NDA NDA017362

Jan 1, 1982

PROGESTASERT

NDA NDA017553

Jul 31, 1997

CRINONE

NDA NDA020701

May 14, 1998

PROMETRIUM

NDA NDA019781

Jun 21, 2007

ENDOMETRIN

NDA NDA022057

Apr 29, 2020

MILPROSA

NDA NDA201110

Sources

References

[1]
ClinicalTrials.gov — 213 trial records for progesterone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Prometrium drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — progesterone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for progesterone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA201110). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Prometrium. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Ferring company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Progesterone Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Ferring

Patent Landscape[6]

Patent Cliff

Feb 3, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10548904Feb 3, 2029

10537584Feb 3, 2029

8580293Jan 21, 2030