Skip to content

Effect of combined oral contraceptives and vitamin E against polycystic ovarian syndrome.

Clinical evaluation of Drospirenone with ethinyl estradiol and vitamin E add on therapy against polycystic ovarian syndrome- an open label pilot randomized controlled study.

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045004
Enrollment
120
Registered
2022-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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: Vitamin E: 200 mg OD for group 2 and 400 mg OD for group 3 for 3 months Control Intervention1: Drospirenone with ethinyl estradiol: 3mg drospirenone with 20mcg ethinyl estradiol OD for

Sponsors

SRM institute of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with polycystic ovarian syndrome according to Rotterdam criteria and did not use any injectable or implant or hormonal contraceptives within 6 months or oral contraception and IUD within 3 months before the study will be included.

Exclusion criteria

Exclusion criteria: Women who were pregnant, want to get pregnant or suspected of being pregnant, breastfeeding women, contraindicated for using COCs, diagnosed with concomitant hyperthyroidism, Hyperprolactinemia, diabetes mellitus, renal, or adrenal insufficiency will be excluded.

Design outcomes

Primary

MeasureTime frame
Drospirenone and ethinyl estradiol with vitamin E supplements may be better than drospirenone and ethinyl estradiol in relation with oxidative stress as well as hormone balance. Adolescents administered with vitamin E can have regular cycles with improvement in acne and hirsutism like symptoms.Timepoint: Total testosterone, and follicle stimulating hormone (FSH) and insulin resistance by Homa- IR, Total Antioxidant Capacity (TAC), Glutathione (GSH).

Secondary

MeasureTime frame
Hirsutism and acne may be improved in adults as well as adolescents.Timepoint: Acne and Hirsutism.

Countries

India

Contacts

Public ContactDr M Sumithra

Department of Obstetrics and Gynecology, SRM Medical College Hospital and Research Centre

anuthanigai77@gmail.com

Outcome results

None listed

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