OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

NCT03236740 | Completed Phase 4

• 1 other identifier: OG/2017/12
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

Metformin

ACTIVE COMPARATOR

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

Drug: Metformin Hydrochloride

OCP

ACTIVE COMPARATOR

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

Interventions

Ethinyl Estradiol-cyprosterone acetate DRUG

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

OCP

Metformin Hydrochloride DRUG

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

Metformin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed with PCOS according to the Rotterdam criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• S.C.B. Medical College and Hospital: lead

Study Sites (1)

SCB Medical College

Cuttack, Odisha, 753007, India

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Priyadarshini Tripathy, MD

  SCB Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2017
• First Posted: August 2, 2017
• Study Start: August 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 15, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

IN (1)