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Completed

NCT Number: NCT03236740

OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

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.

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Key information

Conditions

PCOS

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

SCB Medical College

Cuttack, Odisha, 753007, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethinyl Estradiol-cyprosterone acetate

Drug

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

Metformin Hydrochloride

Drug

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

Primary outcomes

  1. Changes in ovarian stromal blood flow by using Doppler

    Time frame: 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 outcomes

  1. Change in BMI as measured in kg/m2

    Time frame: 6 months

  2. Improvement in hirsutism measured by Modified Ferriman and Gallwey scores

    Time frame: 6 months

  3. Improvement in menstrual cycle pattern

    Time frame: 6 months

  4. Change in waist circumference (cm)

    Time frame: 6 months

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

    Time frame: 6 months

  6. Change in blood level of Testosterone (nmol/L)

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

  9. Changes in fasting serum insulin levels (mIU/L)

    Time frame: 6 months

  10. Changes in fasting serum glucose levels (mg/dL)

    Time frame: 6 months

  11. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

S.C.B. Medical College and Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2017
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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