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

NCT ID: NCT00911313

Last Updated: 2009-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-01-31

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Letrozole

Group Type: EXPERIMENTAL

Letrozole tablets (Femara; Novartis Pharma, Switzerland)

Intervention Type: DRUG

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

Metformin-CC

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

metformin HCl 1500 daily for 6-8 weeks

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

Intervention Type: DRUG

150 mg CC for 5 days starting from day 3 of menstruation

Interventions

Letrozole tablets (Femara; Novartis Pharma, Switzerland)

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

Intervention Type: DRUG

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

metformin HCl 1500 daily for 6-8 weeks

Intervention Type: DRUG

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

150 mg CC for 5 days starting from day 3 of menstruation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• CC resistant PCOS

Exclusion Criteria

• Congenital adrenal hyperplasia
• Cushing syndrome
• Androgen secreting tumors

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mansoura Faculty of Medicine, Mansoura University.

Principal Investigators

Hatem Abu Hashim, MD. MRCOG

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Tarek Shokair, MD

Role: STUDY_DIRECTOR

Mansoura University Hospital

Ahmed Badawy, MD.PhD.

Role: STUDY_CHAIR

Mansoura University Hospital

Locations

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

References

Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.

Reference Type: BACKGROUND

PMID: 16595197 (View on PubMed)

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. doi: 10.1016/j.fertnstert.2006.06.014. Epub 2006 Sep 27.

Reference Type: BACKGROUND

PMID: 17007847 (View on PubMed)

Other Identifiers

FMH-012-G

Identifier Type: -

Identifier Source: secondary_id

MU- 059

Identifier Type: -

Identifier Source: org_study_id