OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

S.C.B. Medical College and Hospital

Status and phase: Completed; Phase 4

Conditions: PCOS

Treatments: Drug: Metformin Hydrochloride; Drug: Ethinyl Estradiol-cyprosterone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT03236740

OG/2017/12

Details and patient eligibility

About

This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal parameters post-treatment.

Enrollment: 101 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women diagnosed with PCOS according to the Rotterdam criteria

Exclusion criteria

• Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
• Medical or surgical treatment of PCOS during the previous 3 months
• Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
• Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months)
• Inability to understand the proposal of the study precluding effective informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Metformin

Active Comparator group

Description:

Metformin 500mg bid in morning and evening after meals to be taken for 6 months.

Treatment:

Drug: Metformin Hydrochloride

OCP

Active Comparator group

Description:

OCP containing 35 microgram ethinylestradiol and 2-milligram cyproterone acetate to taken from the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill. OCP to be taken for 6 months.

Treatment:

Drug: Ethinyl Estradiol-cyprosterone acetate