Estrace

(estradiol)

ApprovedSmall molecule

Estradiol is used to treat symptoms of menopause like hot flashes and vaginal dryness, and to prevent bone loss in postmenopausal women. It's also used as hormone replacement therapy and to treat certain hormone-related cancers and conditions.[2] Estrace is currently approved and in use across 51 indications[4].[1]

Estrace is one of 872 small molecule programs targeting Insulin resistance. It is currently in Approved.

Indications

153

Total Trials

Active Trials

871

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Insulin ResistanceActive, not recruiting

Blood Coagulation DiseaseApproved

ContraceptionActive, not recruiting

HIV InfectionApproved

Systemic Lupus ErythematosusActive, not recruiting

Endothelial DysfunctionActive, not recruiting

Paroxysmal Familial Ventricular FibrillationApproved

Depressive DisorderApproved

HypogonadismActive, not recruiting

Migraine DisorderApproved

Insulin ResistancePreclinical

Active, not recruiting

Blood Coagulation DiseaseApproved

Approved

ContraceptionApproved

Active, not recruiting

HIV InfectionApproved

Approved

Systemic Lupus ErythematosusPreclinical

Active, not recruiting

Endothelial DysfunctionPreclinical

Active, not recruiting

Paroxysmal Familial Ventricular FibrillationApproved

Approved

Depressive DisorderApproved

Approved

HypogonadismApproved

Active, not recruiting

Migraine DisorderApproved

Approved

Showing 10 of 50 indications

Competition

Competitive Landscape

145 competitors in Type 2 Diabetes Mellitus

#DrugCompanyPhaseTrials

Estrace

Novo Nordisk

Approved

153 2

DWP16001

Daewoong Pharmaceutical Co. LTD.

Phase 3

5 3

GZR18

GGan & Lee Pharmaceuticals.

Phase 3

5 4

GZR4

GGan and Lee Pharmaceuticals, USA

Phase 3

5 5

Elecoglipron

AstraZeneca

Phase 3

5 6

Ganagliflozin

HHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Phase 3

1 7

Dorzagliatin

HHua Medicine Limited

Adenocard

1 9

NOVOLIN R

Novo Nordisk

Preclinical

1 10

Dostinex

Pfizer

Preclinical

—

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

Timeline

Expected Milestones

Q4 2026

ApprovedRecruiting

Study completion

NCT06798571

Post-ApprovalRecruiting

Study completion

NCT05282277

Post-ApprovalRecruiting

Postmenopausal Women

NCT07160504

ApprovedRecruiting

Breastfeeding

NCT05457972

Q1 2027

Post-ApprovalActive, not recruiting

Urinary Tract Infection

NCT05723601

Q2 2027

Phase 2Recruiting

Breast Cancer

NCT05716516

Clinical

Trials by Indication[1]

Estrogen8 trials

A Definitive Estrogen Patch Study (ADEPT)

Completed·TThe Alfred·Phase 2·NCT00357006·180 enrolled

Estrogen and Fear in PTSD

Completed·TThe University of Texas Health Science Center, Houston·Phase 3·NCT04192266·83 enrolled

Impact of Estrogen on Fear Extinction R61

Completed·NNYU Langone Health·Phase 1·NCT02673606·136 enrolled

Show 5 more trials

Aging and Estrogen on Cortical Function

Completed·MMassachusetts General Hospital·Phase 1/2·NCT01268046·38 enrolled

The Effects of Estrogen on Artificial Endometrium

Completed·MMemorial Sisli Hospital, Istanbul·N/A·NCT03155048·317 enrolled

Estrogen Receptor Beta and Mood

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT03689543·74 enrolled

Research Investigation of Soy and Estrogen

Completed·UUniversity of Illinois at Chicago·Phase 2·NCT00997893·96 enrolled

The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

Unknown status·FFederal University of São Paulo·Phase 3·NCT00905723·60 enrolled

Atrophic Vaginitis7 trials

A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis

Completed·AAlvogen Pine Brook LLC·Phase 3·NCT02995694·535 enrolled

Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency

Completed· Novo Nordisk logo

Novo Nordisk··NCT01507454·1,613 enrolled

Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00431132·336 enrolled

Show 4 more trials

Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00464971·102 enrolled

Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis

Completed· Novo Nordisk logo

Novo Nordisk·Phase 1·NCT01085877·70 enrolled

Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00465192·230 enrolled

Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis

Completed· Novo Nordisk logo

Novo Nordisk·Phase 1·NCT01486979·58 enrolled

Atrophy6 trials

Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women

Completed·TTherapeuticsMD·Phase 3·NCT02253173·764 enrolled

TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy

Completed·TTherapeuticsMD·Phase 2·NCT02449902·50 enrolled

Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function

Completed·OOhio State University·Phase 4·NCT03493126·59 enrolled

Show 3 more trials

A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

Completed·WWarner Chilcott·Phase 2·NCT02670785·203 enrolled

To Study Generic Estradiol 10 mcg Vaginal Tablets in the Treatment of Vulvar and Vaginal Atrophy in Post Menopausal Women.

Completed·GGlenmark Pharmaceuticals Ltd. India·Phase 3·NCT02668796·522 enrolled

Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy

Completed·PPrasco LLC·Phase 3·NCT03332303·540 enrolled

Menopause5 trials

Mirena and Estrogen for Control of Perimenopause Symptoms and Ovulation Suppression

Completed·UUniversity of Colorado, Denver·N/A·NCT01613131·39 enrolled

Timing Estrogen After MenoPaUSe

Completed·UUniversity of Colorado, Denver·N/A·NCT01605071·53 enrolled

Raloxifene and Rimostil for Perimenopause-Related Depression

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00030147·65 enrolled

Show 2 more trials

COMPASS - COpenhagen MenoPAuSe Study

Recruiting·MMartin Blomberg Jensen·Phase 2·NCT07254429·192 enrolled

Effect of Menopause Hormone Therapy In Postmenopausal Women With CSVD And MCI

Unknown status·—·Phase 2·NCT05982470·328 enrolled

Postmenopausal Women5 trials

Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women

Terminated·UUniversity of Missouri-Columbia·N/A·NCT01633814·4 enrolled

The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women

Completed·WWake Forest University Health Sciences·Phase 1·NCT03681691·12 enrolled

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

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

Show 2 more trials

Postmenopausal Women Estrogen and Progesterone Infusion

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

Vaginal Estrogen Treatment and Effect on Hemostatic Parameters in Postmenopausal Women

Recruiting·UUniversity of Aarhus·Phase 4·NCT07160504·90 enrolled

86 more indications

Breast Cancer4 trials

STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)

Recruiting·—·Phase 2·NCT05716516·36 enrolled

Estrogen for Triple Negative Breast Cancer

Terminated·UUniversity of Wisconsin, Madison·Phase 2·NCT01083641·17 enrolled

Study of Physiological and High Dose Estradiol in the Treatment of Hormone Receptor Positive Metastatic Breast Cancer

Completed·WWashington University School of Medicine·Phase 2·NCT00324259·66 enrolled

Show 1 more trial

Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography

Completed·WWashington University School of Medicine·Phase 2·NCT02455453·47 enrolled

Treatment4 trials

Effects of Tibolone Treatment on the Endometrium

Completed·EErasmus Medical Center·Phase 4·NCT00294463·35 enrolled

E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy

Withdrawn·UUniversity of Pennsylvania·N/A·NCT01986764

Postmenopausal Facial Skin After Estradiol and Genistein Topical Treatment

Completed·FFederal University of São Paulo·Phase 2·NCT01553773·30 enrolled

Show 1 more trial

Evaluation and Treatment of Tall Statured Girls

Unknown status·RRigshospitalet, Denmark··NCT02638922·304 enrolled

Hormone Replacement Therapy3 trials

Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00044837·120 enrolled

Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.

Completed·WWarner Chilcott·Phase 3·NCT01070979·249 enrolled

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

Women3 trials

Menopausal HT for Women Living With HIV (HoT)

Not yet recruiting·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT06856174·105 enrolled

Follicle Stimulating Hormone (FSH) Glycosylation in Women: Effect of Estradiol

Unknown status·—·Phase 2·NCT03868202·10 enrolled

Pilot E2 for Hypogonadal Women With CFBD

Withdrawn·EEmory University·Phase 4·NCT03724955

Prostate Cancer3 trials

Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT00459810·21 enrolled

Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer

Completed·UUniversity of Washington·Phase 2·NCT00167648·17 enrolled

Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

Terminated·UUniversity of Medicine and Dentistry of New Jersey·Phase 2·NCT00176644·23 enrolled

Dyspareunia3 trials

Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women

Completed·AAngelica Lindén Hirschberg·Phase 4·NCT05586711·170 enrolled

Treating Postmenopausal Dyspareunia Where it Hurts

Completed·OOregon Health and Science University·Phase 4·NCT03240081·50 enrolled

A Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Inserts 4 mcg (Teva Pharmaceuticals, Inc.) With IMVEXXY® (Estradiol Vaginal Inserts) (TherapeuticsMD, Inc.) in the Treatment of Dyspareunia in Women With Vulvar and Vaginal Atrophy

Completed· Teva logo

Teva·Phase 3·NCT05617820·1,050 enrolled

Cognition2 trials

Early Menopause Hormone Treatment and Cognition

Completed·UUniversity of Michigan·N/A·NCT01046643·30 enrolled

Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women

Completed·UUniversity of Colorado, Denver·N/A·NCT02122198·17 enrolled

Ovulation Induction2 trials

Optimizing Ovulation Induction in the Poor Responder

Withdrawn·—·N/A·NCT01200537

Vaginal Estradiol and Oral Guaifenesin in Clomiphene Ovulation Induction

Completed·YYuzuncu Yil University·N/A·NCT07398924·90 enrolled

Schizophrenia2 trials

Estradiol Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder

Completed·TTangent Data·Phase 3·NCT03848234·209 enrolled

Clinical Estradiol Trial in Women With Schizophrenia

Completed·BBayside Health·Phase 2·NCT00206570·100 enrolled

Obesity2 trials

Estrogen Sensitivity and Ovulatory Dysfunction in Obesity

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

Prevention of Obesity in Women Via Estradiol Regulation

Completed·UUniversity of Colorado, Denver·Phase 3·NCT00687739·79 enrolled

Frozen Embryo Transfer2 trials

Estradiol and Progesterone Levels Following Frozen Embryo Transfer

Completed·—·Phase 4·NCT04997525·305 enrolled

The Effect of Sildenafil Citrate on Frozen Embryo Transfer Cycles

Unknown status·—·Phase 2/3·NCT05951413·110 enrolled

Atherosclerosis2 trials

Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000559

Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

Completed·UUniversity of Colorado, Denver·N/A·NCT00608062·155 enrolled

Hot flashes2 trials

Comparison of Hormonal Therapy: Mediating Hot Flashes Tapering Regimens for Mediating Hot Flashes

Unknown status·HHartford Hospital·N/A·NCT00547001·235 enrolled

Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women

Terminated·MMassachusetts General Hospital·Phase 2·NCT01126801·2 enrolled

Interaction2 trials

Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT06005610·93 enrolled

Drug-Drug Interaction Study in Trans Women Living With HIV

Active, not recruiting·MMaple Leaf Research·Phase 4·NCT05663892·45 enrolled

Testosterone2 trials

The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans

Not yet recruiting·UUniversity of British Columbia·N/A·NCT07212712·50 enrolled

Comparison Between Testosterone and Estradiol Over the Homogenization of Follicular Cohort

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 3·NCT03238092·26 enrolled

ESS2 trials

Perimenopausal Effects of Estradiol on Reward Responsiveness

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

Vaginal Creams to Reduce Vaginal Erosion in Pessary Users

Withdrawn·NNorthwell Health·Phase 2·NCT02316249

Estrogen Replacement Therapy2 trials

Perimenopausal Estrogen Replacement Therapy Study

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2/3·NCT01308814·172 enrolled

The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass

Terminated·UUniversity of Chicago·Phase 2·NCT01928082·1 enrolled

Intracytoplasmic Sperm Injection2 trials

Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders

Completed·IInstituto de Investigacion Sanitaria La Fe·Phase 2·NCT01310647·66 enrolled

Timing of Estrogen Support During the Luteal Phase of in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycle

Completed·ZZekai Tahir Burak Women's Health Research and Education Hospital·N/A·NCT01367912·301 enrolled

Urinary Tract Infection2 trials

Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection

Completed·MMayo Clinic·N/A·NCT04301934·12 enrolled

Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream

Active, not recruiting·WWake Forest University Health Sciences·Phase 4·NCT05723601·21 enrolled

Efficacy and Safety2 trials

Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

Terminated· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited·Phase 3·NCT01753102·49 enrolled

Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)

Withdrawn·OOrganon and Co·Phase 3·NCT01723579

Ovarian Function2 trials

A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)

Completed·OOrganon and Co·Phase 2·NCT01709318·666 enrolled

Cardiometabolic Consequences of the Loss of Ovarian Function

Recruiting·UUniversity of Colorado, Denver·Phase 4·NCT06264882·100 enrolled

COVID-192 trials

Estrogen Patch for COVID-19 Symptoms

Terminated·SSharon Nachman·Phase 2·NCT04359329·2 enrolled

Oestrogen Treatment for COVID-19 Symptoms

Unknown status·HHamad Medical Corporation·Phase 2·NCT04853069·2,000 enrolled

Steroid2 trials

Sex Steroids and the Serotonin Transporter

Completed·MMedical University of Vienna·Phase 4·NCT01065220·32 enrolled

Effects of Sex Steroids on the Serotonin System

Unknown status·MMedical University of Vienna·Phase 4·NCT02715232·92 enrolled

Heavy Menstrual Bleeding1 trial

Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding

Unknown status·KKay I Waud MD PhD·N/A·NCT01659008·100 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

Mood Disorder1 trial

The Role of Hormones in Postpartum Mood Disorders

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

Multiple Sclerosis1 trial

POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis

Unknown status·HHospices Civils de Lyon·Phase 3·NCT00127075·300 enrolled

Acceptability1 trial

Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Completed·IInstituto Palacios·Phase 3·NCT04232813·120 enrolled

Systemic Lupus Erythematosus1 trial

Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00006133·970 enrolled

Hysteroscopy1 trial

Pharmacological Preparation of the Cervix for Hysteroscopy

Completed·JJagiellonian University·N/A·NCT05783479·96 enrolled

Antipsychotics1 trial

Estradiol as add-on to Antipsychotics

Unknown status·TTangent Data·Phase 3·NCT04093518·100 enrolled

Function1 trial

Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

Completed·UUniversity Hospital, Ghent·Phase 1/2·NCT00740194·20 enrolled

Bulimia Nervosa1 trial

Neurobiology of Bulimia Nervosa

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT04225221·10 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

Turner syndrome1 trial

Defining the Optimal Hormonal Replacement Therapy in Turner Syndrome

Completed·LLine Cleemann·Phase 4·NCT00134745·43 enrolled

Labour Induction1 trial

Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

Completed·—·Phase 2/3·NCT02485821·200 enrolled

Quality of Life1 trial

Discontinuation of Postmenopausal Hormone Therapy: Impact on the Cardiovascular System and Quality of Life

Unknown status·HHanna Savolainen-Peltonen·Phase 4·NCT04050592·150 enrolled

Anorexia Nervosa1 trial

Estradiol and Fear Extinction in Anorexia Nervosa (AN)

Withdrawn·JJohns Hopkins University·Phase 1·NCT02792153

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

Hypogonadism1 trial

The Effect of Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population

Recruiting·WWalter Reed National Military Medical Center··NCT06247267·75 enrolled

Randomized1 trial

Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial

Withdrawn·VVirginia Commonwealth University·Phase 4·NCT04933240

Progesterone1 trial

Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion

Unknown status·UUniversity of Virginia·Phase 1·NCT04597099·10 enrolled

Vasomotor Symptoms1 trial

Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

Completed· Bayer logo

Bayer·Phase 3·NCT00446199·735 enrolled

Alzheimer's Disease1 trial

Alzheimer's Disease: Therapeutic Potential of Estrogen

Completed·UUniversity of Wisconsin, Madison·Phase 2/3·NCT00066157·42 enrolled

Trial1 trial

Maternal Mental Health Trial

Recruiting·VVibe G Frøkjær, MD, PhD·Phase 1/2·NCT04685148·220 enrolled

Left Ventricular Dysfunction1 trial

Sex Differences in Myocardial Steatosis Induced Left Ventricular Dysfunction

Unknown status·TThe University of Texas at Arlington·Phase 4·NCT04671966·100 enrolled

Insulin Sensitivity1 trial

Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man

Completed·UUniversity Hospital, Caen·Phase 3·NCT02847806·6 enrolled

Postmenopausal Atrophic Vaginitis1 trial

Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00108849·309 enrolled

HIV-1 infection1 trial

Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity

Completed·CCONRAD·Phase 1·NCT01810315·40 enrolled

Mammographic Density1 trial

KEEPS Mammographic Density And Breast Health Ancillary Study

Completed·—·N/A·NCT02524561·517 enrolled

Fibrinolysis1 trial

Coagulation and Fibrinolysis of Estradiol in Transwomen

Terminated·MMedical College of Wisconsin·Phase 1·NCT05387577·6 enrolled

Postpartum Depression1 trial

Postpartum Depression: Transdermal Estradiol Versus Sertraline

Terminated·NNorthwestern University·Phase 4·NCT00744328·85 enrolled

Embryo Transfer1 trial

Comparison of Vaginal and Transdermal Oestrogen Before Frozen Thawed Embryo Transfer

Unknown status·UUniversity Hospital, Angers··NCT03518528·100 enrolled

Randomized Controlled Trial1 trial

A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC

Completed·WWashington University School of Medicine·N/A·NCT00789802·129 enrolled

Cohort Study1 trial

Comparing the Effects of Sublingual Estradiol Treatment Versus Oral Estradiol With Cyproterone Acetate (CPA) Treatment on The Coagulation System in Transgender Women: A Prospective, Controlled Cohort Study

Completed·TTel-Aviv Sourasky Medical Center·N/A·NCT07145281·30 enrolled

MPA1 trial

Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo

Completed·AAmneal Pharmaceuticals, LLC·Phase 3·NCT01779947·519 enrolled

Drug Interactions1 trial

Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women

Completed·TThomas Jefferson University·Phase 1·NCT04283656·8 enrolled

CAR1 trial

Vaginal Estradiol Use in Pessary Care

Terminated·UUniversity of South Florida·Phase 1·NCT05458375·11 enrolled

Postmenopausal Symptoms1 trial

Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms

Completed·BBioSante Pharmaceuticals·Phase 3·NCT00391417·431 enrolled

Recurrent urinary tract infections1 trial

Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women

Terminated· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00560924·6 enrolled

Suicidality1 trial

Neurocognitive Mechanisms of Perimenstrual Estrogen Effects on Suicidality

Terminated·UUniversity of Illinois at Chicago·Phase 2·NCT06191289·11 enrolled

Female1 trial

Investigation of Female Reproductive Hormone Dynamics During Adolescence

Completed·MMassachusetts General Hospital·Phase 1·NCT02486757·9 enrolled

Irritability1 trial

Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT04051320·23 enrolled

Healing1 trial

Trial of Zesteem (Estradiol) in Healing of Split Thickness Skin Graft Donor Sites

Completed·RRenovo·Phase 3·NCT00426972·148 enrolled

Endothelial Function1 trial

Impact of Estradiol on Endothelial Function in Peri-Menopausal Women

Active, not recruiting·UUniversity of Delaware·Phase 4·NCT04255160·80 enrolled

Cardiovascular Disease1 trial

Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women

Completed·MMayo Clinic·Phase 2·NCT03815929·35 enrolled

Recurrent Uti1 trial

Preventing Recurrent UTI With Vaginal Estrogen

Completed·JJohns Hopkins University·Phase 4·NCT05551949·27 enrolled

Prostate Adenocarcinoma1 trial

Prostate Adenocarcinoma TransCutaneous Hormones

Unknown status·UUniversity College, London·Phase 3·NCT00303784·2,200 enrolled

Polycystic Ovary Syndrome1 trial

Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome

Recruiting·UUniversity of Virginia·Phase 1·NCT03401047·37 enrolled

Estrogen Deficiency1 trial

Estrogen Deficiency on Cardiovascular Risk

Not yet recruiting·MMilton S. Hershey Medical Center·Phase 1·NCT06369363·20 enrolled

Hormone Therapy1 trial

Cross-sex Hormone Therapy and Neuronal Plasticity

Unknown status·HHospital de Clinicas de Porto Alegre·N/A·NCT03651427·30 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

Miscarriage1 trial

Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

Completed·—·Phase 2/3·NCT03479879·200 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

TED1 trial

Estradiol Levels in Patients Treated With Estring

Completed·UUniversity of Arizona·Phase 2·NCT01923298·14 enrolled

Aneurysm1 trial

Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial

Withdrawn·RRush University Medical Center·Phase 2·NCT01895881

Acute1 trial

Acute Metabolic Effects of Estradiol

Completed·UUniversity of Aarhus·N/A·NCT00435175·8 enrolled

Estrogen-Receptor Positive Breast Cancer1 trial

PRe-operative ESTradiOl Window of Opportunity Study in Post-Menopausal Women With Newly Diagnosed ER Positive Breast Cancer

Active, not recruiting·AAHS Cancer Control Alberta·Phase 2·NCT02238808·19 enrolled

Post-menopause1 trial

A Study to Compare the Bioequivalence and Adhesion Between a Test Estradiol/Levonorgestrel Transdermal Delivery System (0.045 mg Per Day/0.015 mg Per Day) (Corium TDS) and Reference Climara Pro® at the Same Strength (0.045 mg Per Day / 0.015 mg Per Day) for Seven Days in Post-menopausal Female Participants

Completed·CCorium Innovations, Inc.·Phase 1·NCT07851649·68 enrolled

Osteoporosis1 trial

The Effect of Low-dose Rhythmic 17-β-estradiol Administration on Bone Turnover in Postmenopausal Women

Completed·AAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·Approved·NCT05903820·48 enrolled

Cerebrovascular Disorders1 trial

Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences (Phase 2)

Completed·UUniversity of Wisconsin, Madison·Approved·NCT06253702·22 enrolled

NASH - Nonalcoholic Steatohepatitis1 trial

Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Active, not recruiting·MMassachusetts General Hospital·Phase 3·NCT04833140·50 enrolled

PTSD and Trauma-related Symptoms1 trial

Neuroimaging Study of Fear Learning: Effects of Estrogen

Not yet recruiting·UUniversity of Arizona·Phase 1·NCT07737613·30 enrolled

Breastfeeding1 trial

Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial

Recruiting·UUniversity Hospitals Cleveland Medical Center·Approved·NCT05457972·100 enrolled

PTSD1 trial

The LOW E2 STUDY- Neuroendocrine Risk Mechanisms for Post-traumatic Stress Disorder in Women

Completed·EEmory University·Phase 1·NCT03973229·127 enrolled

Unspecified6 trials

Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Completed·IInstituto Palacios··NCT03385551·120 enrolled

Examining the Effects of Estradiol on Neural and Molecular Response to Reward

Recruiting·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT05282277·103 enrolled

Human Cerebral Blood Flow Regulation

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT04265053·110 enrolled

Show 3 more trials

Transgender Estradiol

Completed·MMedical College of Wisconsin·Phase 1·NCT04036500·11 enrolled

The Influence of Estrogen on the Thermoregulatory Responses to Heat Stress in Pre and Postmenopausal Women

Recruiting·PPenn State University·Approved·NCT06798571·24 enrolled

A Multiple-Center Study to Evaluate the Skin Irritation and Sensitization Potential of a Test Estradiol/Levonorgestrel Transdermal Delivery System (Corium TDS)

Recruiting·CCorium Innovations, Inc.·Phase 1·NCT07794150·250 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

DELESTROGEN

NDA NDA009402

Jan 31, 1984

ESTRACE

NDA ANDA086069

Jul 17, 1986

ESTRACE

NDA ANDA086069

Sep 10, 1986

ESTRADERM

NDA NDA019081

Oct 16, 1987

ESTRACE

NDA ANDA086069

Jun 7, 1991

ESTRACE

NDA ANDA086069

Mar 11, 1992

ESTRACE

NDA ANDA086069

Sep 23, 1992

ESTRACE

NDA ANDA086069

Jan 14, 1994

ESTRACE

NDA ANDA086069

Apr 26, 1996

ESTRING

NDA NDA020472

Dec 3, 1996

FEMPATCH

NDA NDA020417

Dec 31, 1996

ESTRACE

NDA ANDA086069

Sep 9, 1997

ESTRACE

NDA ANDA086069

Aug 3, 1998

ESTRACE

NDA ANDA086069

Aug 4, 1998

ESCLIM

NDA NDA020847

Mar 5, 1999

CLIMARA

NDA NDA020375

Sep 20, 1999

ESTRADIOL

NDA NDA021048

Aug 11, 2000

ESTRACE

NDA ANDA086069

Aug 11, 2000

ESTRACE

NDA ANDA086069

Aug 16, 2000

VIVELLE

NDA NDA020323

Mar 27, 2001

ESTRACE

NDA ANDA086069

Apr 5, 2002

ALORA

NDA NDA020655

May 3, 2002

VIVELLE-DOT

NDA NDA020538

Mar 20, 2003

FEMRING

NDA NDA021367

Oct 9, 2003

ESTRASORB

NDA NDA021371

Feb 9, 2004

ESTROGEL

NDA NDA021166

Jun 8, 2004

MENOSTAR

NDA NDA021674

Aug 20, 2004

FEMTRACE

NDA NDA021633

Aug 17, 2005

ESTRACE

NDA ANDA086069

Dec 15, 2006

ELESTRIN

NDA NDA021813

Jun 4, 2007

DIVIGEL

NDA NDA022038

Jul 27, 2007

EVAMIST

NDA NDA022014

Nov 25, 2009

VAGIFEM

NDA NDA020908

Sep 23, 2014

MINIVELLE

NDA NDA203752

Jun 21, 2017

ESTRACE

NDA ANDA086069

May 29, 2018

IMVEXXY

NDA NDA208564

Aug 15, 2018

ESTRACE

NDA ANDA086069

Nov 30, 2022

ESTRACE

NDA ANDA086069

Feb 15, 2024

ESTRACE

NDA ANDA086069

Sources

References

[1]
ClinicalTrials.gov — 153 trial records for estradiol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Estrace drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — estradiol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for estradiol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA ANDA086069). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Estrace. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novo Nordisk company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Estrogen Receptor Alpha Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novo Nordisk

Patent Landscape[6]

Patent Cliff

Jul 10, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9730900Jul 10, 2028

9833419Jul 10, 2028

9724310Jul 10, 2028

8231906Jul 4, 2030

10537581Nov 21, 2032

19 more patents

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