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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT00911313

Collaborator

(none)

250

Enrollment

Location

Arms

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland) Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt) Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Letrozole	Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days
Active Comparator: Metformin-CC	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

Arm

Intervention/Treatment

Experimental: Letrozole

Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland)

2.5 mg letrozole daily from day 3 of the menses for 5 days

Active Comparator: Metformin-CC

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

Outcome Measures

Primary Outcome 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). []

Secondary Outcome Measures

The occurrence of pregnancy and miscarriage. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 36 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

CC resistant PCOS

Exclusion Criteria:

Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospitals,OB/GYN department	Mansoura	Dakahlia	Egypt	35511

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Hatem Abu Hashim, MD. MRCOG, Mansoura University Hospital
Study Director: Tarek Shokair, MD, Mansoura University Hospital
Study Chair: Ahmed Badawy, MD.PhD., Mansoura University Hospital