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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01008046
First received: November 4, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Drug: combined N-acetyl cysteine -CC
Drug: combined metformin-CC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: N-acetyl Cysteine Plus Clomiphene Citrate Versus Metformin and Clomiphene Citrate in Treatment of Clomiphene-resistant Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Ovulation rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pregnancy rate [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: April 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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
Active Comparator: 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.
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

Detailed Description:

In combined NAC-CC group group,patients received NAC (200 mg per sachet, SEDICO, Egypt) for 5-6 weeks from the 1st day of of spontaneous or induced menstruation (in a dose of 1.8 g orally in three divided doses, 3 sachets per dose). All patients in other group received metformin HCl (Cidophage®; Chemical Industries Development, Egypt), 500 mg thrice daily for 5-6 weeks from the 1st day of spontaneous or induced menstruation. Then after the end of this period, patients in either group received 100 mg CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation, it was increased by 50 mg for the next cycle. Patients continued treatment for three successive cycles using the same protocol. NAC and metformin were 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008046

Locations
Egypt
Mansoura University Hospitals,OB/GYN department
Mansoura, Dakahlia Governorate, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Hatem Abu Hashim, MD. MRCOG Mansoura University Hospitals
Study Chair: Kamal Anwar, MD Mansoura University Hospitals
Study Director: Rafat Abd El-Fatah, MD 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: NCT01008046     History of Changes
Other Study ID Numbers: MU- 183, FMH-112-M
Study First Received: November 4, 2009
Last Updated: November 4, 2009
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
Polycystic ovary syndrome
clomiphene resistance
metformin
N-acetyl cysteine

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Acetylcysteine
Clomiphene
Enclomiphene
Metformin
N-monoacetylcystine
Zuclomiphene
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Expectorants
Fertility Agents
Fertility Agents, Female
Free Radical Scavengers
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 23, 2014