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NCT04597099: CRM010
Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion
EARLY_PHASE1 trial testing Micronized progesterone in PCOS in 10 participants. Status unknown.
1 October 2025
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 10 |
| Start date | 26 October 2022 |
| Primary completion | 1 October 2025 |
| Estimated completion | 1 October 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Micronized progesterone
- Placebo
- Flutamide (flutamide) — full drug profile →
- Estradiol patch — full drug profile →
Conditions studied
- PCOS — all drugs for PCOS →
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
Sponsor
University of Virginia
Who can join
Adults 18 to 30, female only, with PCOS or Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is trying to find out if flutamide (a medication that blocks the effects of testosterone) may help normalize an aspect of pituitary function (specifically, gonadotropin surge generation) in PCOS. This is a randomized, placebo-controlled, double-blinded, crossover study. The investigators hypothesize that in estradiol-pretreated women with PCOS, acute progesterone augmentation of FSH release (positive feedback) will be enhanced by flutamide.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04597099
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Micronized progesterone
Trials testing the same drug.
- NCT05997563 — Adjunctive Vaginal Progesterone in Management of Preterm Labor · Phase 4 · unknown
- NCT04758871 — Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles · Phase 4 · completed
- NCT04225221 — Neurobiology of Bulimia Nervosa · Phase 2 · completed
- NCT04051320 — Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model · Phase 2 · completed
- NCT04108039 — Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles. · NA · completed
Other recruiting trials for PCOS
Currently open trials in the same condition.
- NCT06424860 — Fish Oil, Metformin and Heart Health in PCOS · Phase 1 · recruiting
- NCT06742710 — Liraglutide Treatment in Obese Infertile PCOS Women · Phase 4 · recruiting
- NCT07255911 — Cabergoline & Letrozole Versus Letrozole in Ovulation Induction in PCOS · NA · recruiting
- NCT06793072 — Adipokines in Polycystic Ovary Syndrome · recruiting
- NCT06591169 — Lifestyle Changes in PCOS with OSA and NAFLD · NA · recruiting
Other University of Virginia trials
Trials by the same sponsor.
- NCT05880355 — Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI · EARLY_PHASE1 · not yet recruiting
- NCT07405645 — Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy · NA · recruiting
- NCT07146685 — Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study · Phase 4 · not yet recruiting
- NCT07298941 — Resilience Enhancement Following Sleep Treatment · Phase 2 · recruiting
- NCT07036315 — Meaning in Music-Based Pain Modulation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04597099 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Virginia
- Last refreshed: 2 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04597099.
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