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N-acetyl Cysteine and Clomiphene Citrate or Metformin and Clomiphene Citrate for Women With CC Resistant Polycystic Ovary Syndrome (PCOS).

NCT01008046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2009-11-05

No results posted yet for this study

Summary

The purpose of this study is to compare and determine the efficacy of combined N-acetyl cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

combined N-acetyl cysteine -CC

N-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles

DRUG

combined metformin-CC

Patients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Hatem Abu Hashim, MD. MRCOG · Mansoura University Hospital

  • Kamal Anwar, MD · Mansoura University Hospital

  • Rafat Abd El-Fatah, MD · Mansoura University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01008046 on ClinicalTrials.gov