Letrozole or Combined Metformin Clomiphene Citrate (CC) for Women With CC Resistant Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland); Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt); Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)

• Registration Number: NCT00911313
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Last Update Submitted: 2009-05-28
• Study First Posted: 2009-06-01
• Last Update Posted: 2009-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• CC resistant PCOS

Exclusion Criteria

• Congenital adrenal hyperplasia
• Cushing syndrome
• Androgen secreting tumors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letrozole	Letrozole tablets (Femara; Novartis Pharma, Switzerland)	-
Metformin-CC	metformin HCl (Cidophage®; CID,Cairo, Egypt)	-
Metformin-CC	CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)	-

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
The occurrence of pregnancy and miscarriage.

Trial Locations

Locations (1)

Mansoura University Hospitals,OB/GYN department; 🇪🇬 Mansoura, Dakahlia, Egypt