The Effects of OCP and Metformin on Clinical, Hormonal, Metabolic and Ultrasonographic Characteristics in PCOS

NCT02866786 | Completed Phase 4 DMC

• 1 other identifier: OG/2016/13
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorder in women of reproductive age and is a leading cause of infertility due to anovulation. Oral contraceptive pills (OCPs) are considered as first line medical therapy to regularize menses in woman with PCOS. However they may worsen the metabolic profile of patients by elevating insulin resistance which is already deranged in PCOS. As there is higher prevalence of insulin resistance in Indian women with PCOS, insulin sensitisers like metformin may be more beneficial. Hence this study is undertaken to compare the combined effect of metformin and OCPs on the clinical, hormonal, metabolic and ovarian ultrasonographic characteristics in patients with PCOS and to evaluate whether this combination of drugs is more advantageous than OCPs or metformin alone in improving the clinical and metabolic profile.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (7)

• Improvement in menstrual cycle pattern

  All the participants will be asked to maintain a menstrual calendar and fill a questionnaire before and at the end of study. The questionnaire will include menstrual cycle dates, duration and amount from which improvement of menstrual pattern will be assessed.

  6 months

• Change in Abdominal Fat as measured by Waist Circumference in centimeter

  6 months

• Change in weight as measured in kg

  6 months

• Improvement in hirsutism measured by Modified Ferriman and Gallwey scores

  6 months

• Improvement in glucose tolerance (measured by of fasting plasma glucose and 2-hour post prandial plasma glucose)

  6 months

• Change in waist-to-hip ratio

  6 months

• Change in Body mass index (kg/m2)

  6 months

Secondary Outcomes (16)

• Lipid profile (Cholesterol, LDL, HDL and Triglyceride) improvement

  6 months

• Change in blood level of luteinizing hormone [LH] (mIU/ml)

  6 months

• Change in blood level of 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

Study Arms (2)

OCP only arm

ACTIVE COMPARATOR

OCP containing 35 microgram ethinyl estradiol 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 and cyproterone acetate

Metformin arm

ACTIVE COMPARATOR

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

Drug: Metformin

Interventions

Metformin DRUG

Metformin arm

ethinyl estradiol and cyproterone acetate DRUG

Oral Contraceptive Pill

OCP only arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be included into study who fulfill the Rotterdam diagnostic criteria (2003) for PCOS.

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)

Department of Obstetrics & Gynecology

Cuttack, Odisha, 753007, India

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin; Cyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Mahija Sahu, MD

  S.C.B. Medical College and Hospital

  PRINCIPAL INVESTIGATOR

• Priyadarshini Tripathy, MD

  S.C.B. Medical College and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 15, 2016
• Study Start: August 15, 2016
• Primary Completion: April 20, 2017
• Study Completion: August 1, 2017
• Last Updated: April 20, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)