Numerous clinical trials across Phases 1 through 4 evaluate the therapeutic application of estradiol valerate for reproductive and gynecological conditions, including oral contraception, hormone replacement therapy, female infertility, endometrial dysfunction, and polycystic ovary syndrome. Spanning completed, active, and upcoming protocols, these studies highlight the drug's ongoing evaluation. Research is supported by major pharmaceutical sponsors, such as Bayer, alongside academic medical institutions including Meir Medical Center and Alexandria University.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07041814 | NOT_YET_RECRUITING | Turner Syndrome |
Universiti Kebangsaan Malaysia Medical Centre |
2026-02-15 | PHASE2 |
| NCT07419594 | RECRUITING | PTSD; Intrusive Memories; Intrusion Symptom; Trauma; Intrusion |
Charite University, Berlin, Germany |
2024-08-19 | |
| NCT07379502 | NOT_YET_RECRUITING | PCOS (Polycystic Ovary Syndrome) |
CMH Kharian Medical College |
2026-03-05 | |
| NCT07727863 | COMPLETED | PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles; IVF Outcomes |
Cairo University |
2024-09-13 | |
| NCT03976544 | TERMINATED | Miscarriage; Frozen Embryo Transfer; Natural Cycle; Hormone Replacement Therapy Cycle; Preimplantation Genetic Screening; Euploid Embryos |
CRG UZ Brussel |
2019-05-25 | PHASE4 |
| NCT02330757 | UNKNOWN | Infertility |
Mansoura University |
2016-10-10 | PHASE4 |
| NCT06181305 | UNKNOWN | IVF |
Rahem Fertility Center |
2024-02-24 | PHASE4 |
| NCT05227391 | UNKNOWN | PCOS |
Reproductive & Genetic Hospital of CITIC-Xiangya |
2022-03-16 | |
| NCT04590417 | ACTIVE_NOT_RECRUITING | Drug Interaction |
Thai Red Cross AIDS Research Centre |
2022-01-24 | |
| NCT05300841 | UNKNOWN | PCOS; ICSI |
Sohag University |
2022-05-01 | EARLY_PHASE1 |
| NCT05332106 | COMPLETED | Bioequivalence |
Laboratorios Andromaco S.A. |
2022-03-12 | PHASE1 |
| NCT04901377 | Completed | Oral Contraception |
Bayer |
2021-06-24 | -- |
| NCT04002635 | WITHDRAWN | Infertility, Female; Polycystic Ovary Syndrome; IVF; Ovulation Disorder |
CRG UZ Brussel |
2020-12-01 | PHASE4 |
| NCT05197374 | COMPLETED | Female Infertility |
Alexandria University |
2020-06-01 | PHASE4 |
| NCT03854175 | UNKNOWN | Infertility |
Cairo University |
2019-02 | |
| NCT03832894 | UNKNOWN | Infertility |
Cairo University |
2018-12-01 | PHASE3 |
| NCT03788681 | UNKNOWN | ICSI |
Ain Shams University |
2018-04-01 | PHASE3 |
| NCT06312033 | COMPLETED | Emotion Regulation; Estradiol |
International Research Training Group 2804 |
2018-08-01 | |
| NCT03301233 | COMPLETED | Endometrial Thickness |
Ain Shams University |
2017-11-01 | |
| NCT03346317 | UNKNOWN | Intrauterine Adhesion |
Beijing Obstetrics and Gynecology Hospital |
2017-11-16 | |
| NCT03155048 | COMPLETED | Infertility |
Memorial Sisli Hospital, Istanbul |
2017-05-01 | |
| NCT02161614 | COMPLETED | Flow-mediated Dilation Evaluation of the Brachial Artery |
Federal University of Minas Gerais |
2014-02 | |
| NCT01638923 | COMPLETED | Metrorrhagia |
Bayer |
2012-06 | PHASE3 |
| NCT01419353 | COMPLETED | Infertility |
Meir Medical Center |
2011-08 | PHASE4 |
| NCT01221831 | COMPLETED | Contraception |
Estetra |
2010-09 | PHASE2 |
| NCT00755963 | COMPLETED | Hormone Replacement |
Medical University of Vienna |
2009-05 | PHASE4 |
| NCT01120665 | COMPLETED | Women's Health |
University of Sao Paulo General Hospital |
2002-02 | |
| NCT00805415 | COMPLETED | Ovulation Inhibition |
Bayer |
2003-03 | PHASE2 |
| NCT00860964 | COMPLETED | Osteoporosis |
Peking Union Medical College |
1998-02 | PHASE4 |
| NCT00463450 | Completed | Hormone Replacement Therapy |
Bayer|Navitas Life Sciences GmbH|LKF Laboratory |
2002-05 | Phase 3 |
| NCT00463450 | COMPLETED | Hormone Replacement Therapy |
Bayer |
2002-05 | PHASE3 |
| NCT00490308 | UNKNOWN | Infertility |
Assaf-Harofeh Medical Center |
2007-08 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-02-02)
Check the
Estradiol valerate
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.