OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

Doppler Analysis of Ovarian Stromal Blood Flow Changes After Treatment With Metformin Versus Ethinylestradiol-cyproterone Acetate in Women With Polycystic Ovarian Syndrome

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 Overview

• Status: Completed
• Conditions: PCOS
• Intervention / Treatment: Drug: Metformin Hydrochloride; Drug: Ethinyl Estradiol-cyprosterone acetate

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Orissa
    • Cuttack, Orissa, India, 753007
      • SCB Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin; Metformin 500mg bid in morning and evening after meals to be taken for 6 months.	Drug: Metformin Hydrochloride; Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.
Active Comparator: OCP; 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.	Drug: Ethinyl Estradiol-cyprosterone acetate; Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in hirsutism measured by Modified Ferriman and Gallwey scores	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
Changes in fasting serum insulin levels (mIU/L)	6 months
Change in BMI as measured in kg/m2	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 levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)	6 months
Changes in fasting serum glucose levels (mg/dL)	6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	6 months

Collaborators and Investigators

• Sponsor: S.C.B. Medical College and Hospital
• Investigators: Principal Investigator: Priyadarshini Tripathy, MD, SCB Medical College

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: July 29, 2017
• First Submitted That Met QC Criteria: July 29, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 17, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Estradiol; Metformin; Ethinyl Estradiol
• Other Study ID Numbers: OG/2017/12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No