To compare efficacy and safety of oral contraceptive pill vs pioglitazone in polycystic ovary syndrome (PCOS) women.

To compare efficacy and safety of oral contraceptive pill (Ethinyl estradiol plus drospirenone) vs pioglitazone in polycystic ovary syndrome (PCOS) women.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/024267

Enrollment

120

Registered

2020-03-25

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

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: oral contraceptive pill(Ethinyl estradiol plus drospirenone): Subjects will be randomised to two groups ,group 1 will receive ocp (ethinyl estradiol 30 mcg plus drospirenone 3 mg) once

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group 15-40 years. 2. Drug NaÃ¯ve patients or no hormone therapy in past 6 months. 3. Who are ready to avoid any other medication during trial and 6 months after it. 4. Who are ready to give consent for participation in trial.

Exclusion criteria

Exclusion criteria: 1.History of thromboembolic events 2. pregnancy 3. Breast feeding females 4.Females who are planning to conceive 5.Idiopathic hyperandrogenism 6. Non classical hyperandrogenism 7.Cushing syndrome and androgen secreting tumors 8.Patient on current hormonal therapy 9.Thyroid dysfunction 10.Liverdisease 10.

Design outcomes

Primary

Measure	Time frame
FG score, serum testosterone, IS (HOMA, MATSUDA, QUICKI, WBISI), Glucose toleranceTimepoint: 0 months, 3 months, 6 months	—

Secondary

Measure	Time frame
Menstrual cyclicity, BMI, Waist circumference(WC), acne, inflammatory markers (CRP, IL6 and TNF alpha).Timepoint: o months, 3 months, 6 months	—

Countries

India

Contacts

Public ContactDrTripti Sharma

Sher-i-Kashmir Institute of Medical Sciences Soura, Srinagar

ashraf.endo@gmail.com9419041546

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026