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

Mansoura University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland); Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt); Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt)

Study type: Interventional

Funder types: Other

Identifiers

NCT00911313

MU- 059

FMH-012-G

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: Female

Ages: 20 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CC resistant PCOS

Exclusion criteria

• Congenital adrenal hyperplasia
• Cushing syndrome
• Androgen secreting tumors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Letrozole

Experimental group

Treatment:

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

Metformin-CC

Active Comparator group

Treatment:

Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)

Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt)