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NCT Number: NCT02866786

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

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.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Obstetrics & Gynecology

Cuttack, Odisha, 753007, India

About this study

We aim to enroll about 120 patients fulfilling the Rotterdam diagnostic criteria for PCOS in our study. Patients will have a baseline clinical examination (Body weight, Body mass index, Waist circumference, Hirsutism score), hormonal profile (FSH, LH, fasting Insulin/glucose ratio, DHEAS, testosterone levels), metabolic profile (fasting and 2 hour post prandial plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides level), ultrasound examination (ovarian volume and subcapsular follicle count, stromal echogenicity) and doppler blood flow study (ovarian stromal velocity, Pulsatility index, Resistivity index, Systolic/Diastolic ratio and stromal vascularization index).

Patients will be then randomized using a computer generated randomization program into two groups according to BMI (<25 and >25). The randomization will be stratified in order to achieve a homogenous distribution of PCOS patients in both arms of the study with respect to age and body mass index. Each group will be further subdivided into three treatment arms. 1st treatment arm will receive OCP containing 35 microgram ethinyl estradiol and 2 mg cyproterone acetate cyclically (21 days regimen) daily; 2nd treatment arm will receive OCP containing 35 microgram ethinyl estradiol and 2 mg cyproterone acetate cyclically (21 days regimen) while the 3rd treatment arm will receive OCP plus metformin 500 mg twice daily for a period of six months. Each patient will be asked to keep a diary of her menstrual periods over the study period. The patients will be followed up at 3 and 6 months of treatment to evaluate the changes in the above mentioned parameters. Analysis of the data will be done through descriptive and perceptive statistical methods by using Statistical Package for the Social Sciences (SPSS) software.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

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

metformin

Drug

ethinyl estradiol and cyproterone acetate

Drug

Oral Contraceptive Pill

Primary outcomes

  1. Improvement in menstrual cycle pattern

    Time frame: 6 months

    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.

  2. Change in Abdominal Fat as measured by Waist Circumference in centimeter

    Time frame: 6 months

  3. Change in weight as measured in kg

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

  6. Change in waist-to-hip ratio

    Time frame: 6 months

  7. Change in Body mass index (kg/m2)

    Time frame: 6 months

Secondary outcomes

  1. Lipid profile (Cholesterol, LDL, HDL and Triglyceride) improvement

    Time frame: 6 months

    The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured in mg/dl before and after of treatment in both groups.

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

    Time frame: 6 months

  3. Change in blood level of follicle stimulating hormone [FSH] (mIU/ml)

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

  6. Change in Free androgen Index (FAI)

    Time frame: 6 months

    Free Androgen Index or FAI is a ratio used to determine abnormal androgen status. The ratio is the total testosterone level divided by the sex hormone binding globulin (SHBG) level, and then multiplying by 100.

  7. Change in Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

    Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin concentrations. HOMA-IR = (Glucose x Insulin) / 405; Glucose is expressed in mg/dl and Insulin is expressed in mIU/L

  10. Ovarian Stromal artery Pulsatility index

    Time frame: 6 months

  11. Ovarian Stromal artery Resistivity index

    Time frame: 6 months

  12. Chang in ovarian Follicle number by Ultrasonography (USG)

    Time frame: 6 months

    Largest cross-sectional plane of the ovary will be evaluated for follicle number

  13. Change in ovarian Follicle diameter (in mm) by USG

    Time frame: 6 months

    Largest cross-sectional plane of the ovary will be evaluated for follicle diameter

  14. Change in Ovarian volume (in cc) by USG

    Time frame: 6 months

    Ovarian volume, estimated according to the formula 1/2 (A x B x C), where A is the longitudinal diameter, B the anteroposterior diameter, and C the transverse diameter of the ovary

  15. Change in Endometrial thickness (in mm)

    Time frame: 6 months

  16. Change in ovarian stromal/total area ratio (S/A)

    Time frame: 6 months

    Ovarian area, evaluated by outlining with the caliper the external limits of the ovary in the maximum plane section. Ovarian stromal area, evaluated by outlining with the caliper the peripheral profile of the stroma, identified by a central area slightly hyperechoic with respect to the other ovarian area.

Sponsors and collaborators

Lead sponsor

S.C.B. Medical College and Hospital

Other

Registry information

Official study title

The Effects of Treatment With Oral Contraceptive Pill Containing Ethinyl Estradiol-Cyproterone Acetate and Metformin on Clinical, Hormonal, Metabolic and Ultrasonographic Characteristics in Polycystic Ovarian Syndrome

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2016
Registry last updated
Apr 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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