TheraRadar
Data updated: May 26, 2026

ESTRADIOL AND PROGESTERONE (estradiol)

Women's Health Approved 2022-05-16
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Discontinued
First Approved
2022-05-16
Routes
ORAL
Dosage Forms
CAPSULE

Companies

AMNEAL PHARMS
Active Ingredient: ESTRADIOL , PROGESTERONE

ESTRADIOL AND PROGESTERONE Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2022 to 2025
Sep 2025 SUPPL
Label · Labeling
May 2022 ORIGINAL
Update
FDA Letter

What ESTRADIOL AND PROGESTERONE Treats

1 FDA approvals

Originally approved for its first indication in 2022 .

  • Other (1)
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Clinical Trial Registry

33 trials
Trial Sponsor ID Phase Status Title
NCT05716516 ESTHER STUDY02001740 NCI-2023-05453 Ph 2 recruiting STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)
NCT06005610 GETITRIgHT results posted A5403 38806 Ph 2 terminated Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
NCT05457972 STUDY20220578 Ph 4 recruiting Postpartum Vaginal Estrogen for Breastfeeding Patients
NCT04192266 results posted HSC-MS-23-0497 R33MH111907 Ph 3 completed Estrogen and Fear in PTSD
NCT03689543 results posted 180144 18-M-0144 Ph 2 completed Estrogen Receptor Beta and Mood
NCT06253702 2023-0548 1R01HL150361-01, EDUC/KINESIOLOGY Ph 4 completed Brain Blood Flow Responses to Stress: Sex Differences
NCT02238808 PRESTO EER001 Ph 2 active not recruiting A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers
NCT05617820 71836003 Ph 3 completed Study Comparing Estradiol Vaginal Inserts 4mcg To IMVEXXY ® (Estradiol Vaginal Inerts 4 mcg) In The Treatment Of Dyspareunia in Women With Vulvur and Vaginal Atrophy
NCT04225221 results posted 19-2343 R21MH121726 Ph 2 completed Neurobiology of Bulimia Nervosa
NCT04933240 HM20021901 Ph 4 withdrawn Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial
NCT01923298 results posted 13-0477-04 EString Ph 2 completed Estradiol Levels in Patients Treated With Estring
NCT03493126 results posted 2018H0006 Ph 4 completed Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
NCT02995694 results posted 71462901 Ph 3 completed A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
NCT01441635 results posted M12-663 Ph 2 completed Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
NCT01895881 EPPA EPPA - 12101906 Ph 2 withdrawn Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial
NCT00997893 RISE results posted 2009-0052 5R01MH083782-05 Ph 2 completed Research Investigation of Soy and Estrogen
NCT03848234 EST-S-01 Ph 3 completed Estradiol Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder
NCT02455453 results posted 201411005 5R01CA195450-03 Ph 2 completed Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography
NCT01083641 results posted CO09711 H-2009-0172, NCI-2011-00618 Ph 2 terminated Estrogen for Triple Negative Breast Cancer
NCT02255175 PEERS results posted 13-3572 K12HD001441-15, K23MH105569-01A1 Ph 4 completed Perimenopausal Effects of Estradiol on Reward Responsiveness
NCT01942668 REPLENISH results posted TXC12-05 REPLENISH Trial Ph 3 completed A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms
NCT03479879 AS1731 Ph 2, Ph 3 completed Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage
NCT01753102 CLR_10_19 CTRI/2012/09/002983 Ph 3 terminated Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
NCT02792153 IRB00030009 Ph 1 withdrawn Estradiol and Fear Extinction in Anorexia Nervosa (AN)
NCT01126801 results posted 2009p001776 Ph 2 terminated Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women
NCT01308814 PERT results posted 10-0542 R01MH087619 Ph 2, Ph 3 completed Perimenopausal Estrogen Replacement Therapy Study
NCT02253173 REJOICE results posted TXV14-01 Ph 3 completed Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
NCT02485821 MS39825273 Ph 2, Ph 3 completed Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol
NCT02449902 results posted TXV13-01 Ph 2 completed TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
NCT02316249 NSHS-P001 Ph 2 withdrawn Vaginal Creams to Reduce Vaginal Erosion in Pessary Users
NCT01310647 FOLLPRIM 2009-018009-26 2009-018009-26 Ph 2 completed Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders
NCT01065220 AP13214ONB Ph 4 completed Sex Steroids and the Serotonin Transporter
NCT00740194 2007/279 Ph 1, Ph 2 completed Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ESTRADIOL AND PROGESTERONE FDA Label Details

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Data Sources

FDA Approval: ANDA214293 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.