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OpenTrials
Completed

NCT Number: NCT00911313

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

20 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CC resistant PCOS

Exclusion criteria

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

Treatment and study plan

Letrozole tablets (Femara; Novartis Pharma, Switzerland)

Drug

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

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

Drug

metformin HCl 1500 daily for 6-8 weeks

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

Drug

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

Primary outcomes

  1. 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 outcomes

  1. The occurrence of pregnancy and miscarriage.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 1, 2009
Registry last updated
Jun 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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