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Comparison of effects of three common contraceptive pills, two low estrogen dose and one with higher estrogen and all with different non-androgenic progesterone on metabolic and endocrine parameters in women diagnosed with PCOS

RANDOMIZED CONTROL TRIAL TO COMPARE EFFECTS OF ULTRA LOW DOSE (ETHINYL ESTRADIOL 20µG OR 15µG) WITH LOW DOSE (ETHINYL ESTRADIOL 30µG) HORMONAL PILLS ON LIPID DISCORDANCE IN NON-OBESE PCOS WOMEN

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011920
Enrollment
123
Registered
2018-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: null- Lipid profile,free androgen index and basal insulin of non-obese PCOS women Health Condition 2: E888- Other specified metabolic disorders

Interventions

Intervention1: DRONIS 20 and MINNESE 15: I) Ethinyl estradiol (20mcg) and Drosperinone (3mg) for 12months with cyclical regime of 24 days II) Ethinyl estradiol (15mcg) and Gestodene(60mcg) for 12mont

Sponsors

Chittaranjan Seva Sadan and Sishu Sadan College of Obstetrics Gynaecology and Child Health
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of PCOS according to Rotterdam criteria with Excessive acne Androgenic alopecia or hirsutism (terminal hair in male pattern distribution) and Oligomenorrhea (cycles more than 35 days apart but less than 6months apart) or amenorrhea (absence of menstruation for 6-12 months after a cyclic pattern has been established).

Exclusion criteria

Exclusion criteria: Women with BMI =25 Age=35 years Smoker Women with active liver disease Women with known coagulation disorders Undiagnosed vaginal bleeding Women who took OCP in preceding 3months Amenorrhea for=1year Women with secondary causes of hyperandrogenism like Cushing syndrome, late onset Congenital adrenal hyperplasia, gross hypothyroidism and hyperprolactinemia

Design outcomes

Primary

MeasureTime frame
Proportion of users with TC/HDL and LDL discordance Timepoint: 12 months

Secondary

MeasureTime frame
LDL/HDL ratio, HOMA-IR and Free Testosterone level , sFG score Timepoint: 6month and one year

Countries

India

Contacts

Public ContactSubhankar Dasgupta

Chittaranjan Seva Sadan and Sishu Sadan, College of Obstetrics Gynaecology and Child Health

subhankar74@gmail.com91-9874836437

Outcome results

None listed

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