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N-acetyl Cysteine Plus Clomiphene Citrate Versus Metformin and Clomiphene Citrate in Treatment of Clomiphene-resistant Polycystic Ovary Syndrome


N/A
20 Years
36 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

N-acetyl Cysteine Plus Clomiphene Citrate Versus Metformin and Clomiphene Citrate in Treatment of Clomiphene-resistant Polycystic Ovary Syndrome


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.


Inclusion Criteria:



- CC resistant PCOS

Exclusion Criteria:

- Congenital adrenal hyperplasia

- Cushing syndrome

- Androgen secreting tumors

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ovulation rate

Safety Issue:

No

Principal Investigator

Hatem Abu Hashim, MD. MRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mansoura University Hospitals

Authority:

Egypt: Institutional Review Board

Study ID:

MU- 183

NCT ID:

NCT01008046

Start Date:

April 2007

Completion Date:

June 2009

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic ovary syndrome
  • clomiphene resistance
  • metformin
  • N-acetyl cysteine
  • Polycystic Ovary Syndrome

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