Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone...
Brief Summary
Official Title: “Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome”
The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: January 2009
Detailed Clinical Trial Description
Withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation. In the letrozole group, 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days, whereas all patients in the combined metformin-CC group) received metformin HCl [Cidophage®; Chemical Industries Development(CID), Cairo, Egypt], 500 mg three times daily for 6-8 weeks. Then after the end of this period, they received 150 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of menstruation. Patients continued treatment for three successive cycles using the same protocol. Metformin was stopped only when pregnancy was documented.
Intervention(s) in this Clinical Trial
- Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland)
- 2.5 mg letrozole daily from day 3 of the menses for 5 days
- Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt)
- metformin HCl 1500 daily for 6-8 weeks
- Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)
- 150 mg CC for 5 days starting from day 3 of menstruation
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Letrozole
- Active Comparator: Metformin-CC
Outcome Measures for this Clinical Trial
Primary Measures
- Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).
- Safety Issue?: No
Secondary Measures
- The occurrence of pregnancy and miscarriage.
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- CC resistant PCOS
Exclusion Criteria:
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 36 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Mansoura University Other
Overall Clinical Trial Officials and Contacts
Hatem Abu Hashim, MD. MRCOG Principal Investigator Mansoura University Hospitals
Related Publications
References
Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. Review.
Siebert TI, Kruger TF, Steyn DW, Nosarka S. Is the addition of metformin efficacious in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome? A structured literature review. Fertil Steril. 2006 Nov;86(5):1432-7. Epub 2006 Sep 27. Review.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00911313
Study ID Number: MU- 059
ClinicalTrials.gov Identifier: NCT00911313
Health Authority: Egypt: Institutional Review Board
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00911313
