OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

Phase 4

Completed

• Conditions: PCOS
• Interventions: Drug: Ethinyl Estradiol-cyprosterone acetate; Drug: Metformin Hydrochloride

• Registration Number: NCT03236740
• Lead Sponsor: S.C.B. Medical College and Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-29
• Study First Submitted QC: 2017-07-29
• Study Start: 2017-08-01
• Study First Posted: 2017-08-02
• Status Verified: 2018-03
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-15
• Last Update Submitted: 2018-03-17
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

Inclusion Criteria

• Women diagnosed with PCOS according to the Rotterdam criteria

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCP	Ethinyl Estradiol-cyprosterone acetate	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.
Metformin	Metformin Hydrochloride	Metformin 500mg bid in morning and evening after meals to be taken for 6 months.

Primary Outcome Measures

Name	Time	Method
Changes in ovarian stromal blood flow by using Doppler	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in BMI as measured in kg/m2	6 months
Improvement in hirsutism measured by Modified Ferriman and Gallwey scores	6 months
Improvement in menstrual cycle pattern	6 months
Change in waist circumference (cm)	6 months
Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml)	6 months
Change in blood level of Testosterone (nmol/L)	6 months
Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)	6 months
Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)	6 months
Changes in fasting serum insulin levels (mIU/L)	6 months
Changes in fasting serum glucose levels (mg/dL)	6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	6 months

Trial Locations

Locations (1)

SCB Medical College; 🇮🇳 Cuttack, Orissa, India