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NCT01909141
Combined Letrozole-metformin-pioglitazone Versus Combined Clomiphene Citrate-metformin-pioglitazone in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome
EARLY_PHASE1 trial testing induction of ovulation using letrozole-pioglitazone-metformin in Polycystic Ovary Syndrome in 100 participants. Completed in 1 April 2014.
1 February 2014
Quick facts
| Lead sponsor | Cairo University |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 August 2013 |
| Primary completion | 1 February 2014 |
| Estimated completion | 1 April 2014 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- induction of ovulation using letrozole-pioglitazone-metformin — full drug profile →
- induction of ovulation using clomiphene citrate-pioglitazone-metformin — full drug profile →
- transvaginal ultrasound
- body mass index (BMI) calculation
- day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone
- pretreatment blood urea and serum creatinine
- serum estradiol (E2) on day 12
- serum progesterone on day 21
- blood urea and serum creatinine every month
Conditions studied
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
- Infertility — all drugs for Infertility →
Sponsor
Cairo University
Who can join
Adults 20 to 40, female only, with Polycystic Ovary Syndrome or Infertility. 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.
-
Ovulation Rate
Time frame: 3 months
Sponsor's own description
Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Drug repurposing for cancer therapy.
Xia Y, Sun M, Huang H, Jin WL. · · 2024 · cited 229× · PMID 38637540 · DOI 10.1038/s41392-024-01808-1 -
Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials.
Federer C, Yoo M, Tan AC. · · 2016 · cited 23× · PMID 27631620 · DOI 10.1089/adt.2016.742 -
A randomized controlled trial of clomifene citrate, metformin, and pioglitazone versus letrozole, metformin, and pioglitazone for clomifene-citrate-resistant polycystic ovary syndrome.
El-khayat W, Abdel Moety G, Al Mohammady M, Hamed D. · · 2016 · cited 21× · PMID 26613820 · DOI 10.1016/j.ijgo.2015.06.063
Verify or expand the search:
- PubMed search for NCT01909141
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Cairo 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 NCT01909141 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cairo University
- Last refreshed: 30 September 2015
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/NCT01909141.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing