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NCT00461643
Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial
Phase 4 trial testing Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins in Anovulatory Infertility Related to Polycystic Ovary Syndrome in 552 participants. Status unknown.
1 December 2015
Quick facts
| Lead sponsor | University Magna Graecia |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 552 |
| Start date | 1 January 2007 |
| Primary completion | 1 December 2015 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins — full drug profile →
Conditions studied
- Anovulatory Infertility Related to Polycystic Ovary Syndrome — all drugs for Anovulatory Infertility Related to Polycystic Ovary Syndrome →
Sponsor
University Magna Graecia
Who can join
Adults 18 to 35, female only, with Anovulatory Infertility Related to Polycystic Ovary Syndrome. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Multiple pregnancy rate
Time frame: 9 months
Sponsor's own description
Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy. The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00461643
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT00461643 (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 Magna Graecia
- Last refreshed: 5 April 2013
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/NCT00461643.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing