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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00911313
First Posted: June 1, 2009
Last Update Posted: June 1, 2009
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.
Information provided by:
Mansoura University
  Purpose
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 Intervention
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)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mansoura University:

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

Enrollment: 250
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Criteria

Inclusion Criteria:

  • CC resistant PCOS

Exclusion Criteria:

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00911313


Locations
Egypt
Mansoura University Hospitals,OB/GYN department
Mansoura, Dakahlia, Egypt, 35511
Sponsors and Collaborators
Mansoura University
Investigators
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
  More Information

Publications:
Responsible Party: Dr. Hatem Abu Hashim, Associate Prof. of OB/GYN, Mansoura Faculty of Medicine, Mansoura University.
ClinicalTrials.gov Identifier: NCT00911313     History of Changes
Other Study ID Numbers: MU- 059
FMH-012-G
First Submitted: May 28, 2009
First Posted: June 1, 2009
Last Update Posted: June 1, 2009
Last Verified: May 2009

Keywords provided by Mansoura University:
Polycystic ovary syndrome
clomiphene resistance
letrozole

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Citric Acid
Letrozole
Clomiphene
Enclomiphene
Zuclomiphene
Hypoglycemic Agents
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists