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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00911313
First received: May 28, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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). [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The occurrence of pregnancy and miscarriage. [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 36 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 28, 2009
Last Updated: May 28, 2009
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Clomiphene
Metformin
Letrozole
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Hypoglycemic Agents
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014