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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911313
• Other study ID #: MU- 059
• Secondary ID: FMH-012-G
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: May 28, 2009
• Start date: June 2006
• Est. completion date: January 2009

Study information

• Verified date: May 2009
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 36 Years

Eligibility

Inclusion Criteria:

• CC resistant PCOS

Exclusion Criteria:

• Congenital adrenal hyperplasia

• Cushing syndrome

• Androgen secreting tumors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Letrozole tablets (Femara; Novartis Pharma, Switzerland)
2.5 mg letrozole daily from day 3 of the menses for 5 days
• metformin HCl (Cidophage®; CID,Cairo, Egypt)
metformin HCl 1500 daily for 6-8 weeks
• CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt)
150 mg CC for 5 days starting from day 3 of menstruation

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals,OB/GYN department	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).			No
Secondary	The occurrence of pregnancy and miscarriage.			No