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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00911313
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : June 1, 2009
Information provided by:
Mansoura University

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) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

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

Primary Outcome Measures :
  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 Outcome Measures :
  1. The occurrence of pregnancy and miscarriage.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CC resistant PCOS

Exclusion Criteria:

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00911313

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Mansoura University Hospitals,OB/GYN department
Mansoura, Dakahlia, Egypt, 35511
Sponsors and Collaborators
Mansoura University
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Principal Investigator: Hatem Abu Hashim, MD. MRCOG Mansoura University Hospitals
Study Director: Tarek Shokair, MD Mansoura University Hospitals
Study Chair: Ahmed Badawy, MD.PhD. Mansoura University Hospitals

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Responsible Party: Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University. Identifier: NCT00911313     History of Changes
Other Study ID Numbers: MU- 059
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: June 1, 2009
Last Verified: May 2009
Keywords provided by Mansoura University:
Polycystic ovary syndrome
clomiphene resistance
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Hypoglycemic Agents
Physiological Effects of Drugs
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists