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NCT01773772: JCM017
Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls
Phase 1 trial testing Progesterone in Female Puberty in 14 participants. Completed in 8 June 2009.
8 June 2009
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 14 |
| Start date | 8 February 2005 |
| Primary completion | 8 June 2009 |
| Estimated completion | 8 June 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Progesterone (Progesterone plus HCG) — full drug profile →
- Placebo
Conditions studied
- Female Puberty — all drugs for Female Puberty →
Sponsor
University of Virginia
Who can join
Adults 9 to 14, female only, with Female Puberty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to learn more about how gonadotropin-releasing hormone (GnRH) and luteinizing hormone (LH) pulses are controlled during puberty. In this study, the investigators aim to discover whether or not giving 2 small doses of progesterone to early pubertal girls will prevent the nighttime increase of GnRH and LH pulses. From the information gathered in this study, the investigators may be able to learn more about how menstrual cycles are normally established in girls during puberty. Ultimately, if these normal processes can be understood, the investigators may be able to better understand abnormalities of puberty.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01773772
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06851754 — Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency · Phase 3 · recruiting
- NCT06928844 — Role of Low Dose Injectable Progesterone in Triggering Ovulation · NA · recruiting
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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 NCT01773772 (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: 14 October 2020
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/NCT01773772.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing