OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

S.C.B. Medical College and Hospital101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

PCOS

Interventions

Ethinyl Estradiol-cyprosterone acetateDRUG

Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.

Metformin HydrochlorideDRUG

Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

SCB Medical College

Cuttack, Odisha, India

Outcomes

Primary Outcomes

Changes in ovarian stromal blood flow by using Doppler

By means of color and power Doppler flow imaging, color signals will be searched in the ovarian stroma away from the ovarian surface and not adjacent to the wall of a follicle. Areas of maximum color intensity, representing the greatest Doppler frequency shifts, will be chosen for pulsed Doppler examination.

Time frame: 6 months

Secondary Outcomes

Change in BMI as measured in kg/m2

Time frame: 6 months

Improvement in hirsutism measured by Modified Ferriman and Gallwey scores

Time frame: 6 months

Improvement in menstrual cycle pattern

Time frame: 6 months

Change in waist circumference (cm)

Time frame: 6 months

Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml)

Time frame: 6 months

Change in blood level of Testosterone (nmol/L)

Time frame: 6 months

Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)

Time frame: 6 months

Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)

Time frame: 6 months

Changes in fasting serum insulin levels (mIU/L)

Time frame: 6 months

Data from ClinicalTrials.gov

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