A clinical trial to study the effect of two drugs metformin and spironolactone in polycystic ovarian syndrome

Comparison of efficacy of metformin and spironolactone in the management of polycystic ovarian syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000031

Enrollment

100

Registered

2009-01-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: metformin 1000 mg daily: 1000 mg daily for 6 months Intervention2: Spironolactone- 50 mg daily for 6 months: 50 mg daily for 6 months Control Intervention1: No control agent used: NA

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion- Females 15-45 years age with menstrual irregularities, hirsuitism and or infertility Diagnosis of PCOS according to Rotterdam criteria

Exclusion criteria

Exclusion criteria: Exclusion criteria- Hypothyroidism, hyperprolactinemia , Cushing?s syndrome and CAH and history of intake of drugs aldactone/ metformin or history of OCP use or intake of drugs known to interfere with carbohydrate metabolism prior 4 weeks before enrolment.

Design outcomes

Primary

Measure	Time frame
Improvement in hirsuitism score and menstrual cycles Timepoint: 0 and 6 months	—

Secondary

Measure	Time frame
Change in body weight, androgens, glycemic status and insulin levels.Timepoint: 0 and 6 months	—

Countries

India

Contacts

Public ContactProf. AC Ammini

aca433@yahoo.com01126593645

Outcome results