Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

Polycystic Ovarian Syndrome Clinical Trial

Official title:

Insulin Sensitizing Agent (Metformin) Improves Clinical Pregnancy Rate and Insulin Parameters in Polycystic Ovarian Syndrome Patients With Acanthosis Nigricans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562664
• Other study ID #: MPCOS
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically, PCOS can identify during the early adolescence. Insulin resistance is a common finding in the obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition of its more common connection to obesity and insulin resistance allows for diagnosis of related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular randomized, double-blind, placebo-controlled trial . The first pharmacological approach to induction of ovulation in women with PCOS is clomiphene citrate

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• All patients with PCOS fulfilled at least 2 out of the three criteria of Rotterdam consensus 2003

Exclusion Criteria:

• liver disease

• heart or respiratory failure

• alcohol abuse

• kidney disease

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Reproductive Endocrinology
• Syndrome

Intervention

Drug:
• CC
100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle
• Placebo tablets
Placebo tablets taken twice daily continuously for three cycles.
• Metformin
wMetformin (Cidophage , Amon , Egypt) 500 mg twice daily continuously for three cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate		6 months
Secondary	Fasting glucose (mg/dl)		6 months
Secondary	Fasting insulin (mg/dl)		6 months