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NCT02244567: U-C OC IN PCOS
Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin in Hyperandrogenic Lean PCOS Women
Phase 1 trial testing Metformin 850 mg twice daily for 3 months in Polycystic Ovarian Syndrome in 100 participants. Status unknown.
1 June 2021
Quick facts
| Lead sponsor | Beni-Suef University |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 September 2014 |
| Primary completion | 1 June 2021 |
| Estimated completion | 1 June 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Metformin 850 mg twice daily for 3 months — full drug profile →
- Serum uc-oc
- drug
Conditions studied
- Polycystic Ovarian Syndrome — all drugs for Polycystic Ovarian Syndrome →
Sponsor
Beni-Suef University
Who can join
Adults 20 to 30, female only, with Polycystic Ovarian Syndrome. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
High Serum under-carboxylated osteocalcin
Time frame: 3 months
Hyperandrogenic lean women will be diagnosed as PCOS according to Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.Serum uc-oc will be assayed when it is found to be high, metformin therapy for three months will be given to these women. Serum uc-oc will be measured again and effect of therapy will be interpreted.
Sponsor's own description
High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women trying to interfere with the pathophysiology of PCOS in these women as followed up by serum UC-OC levels.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02244567
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Polycystic Ovarian Syndrome
Currently open trials in the same condition.
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Other Beni-Suef University trials
Trials by the same sponsor.
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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 NCT02244567 (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 Beni-Suef University
- Last refreshed: 30 January 2021
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/NCT02244567.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing