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Polycystic Ovary SyndromePhase 4NCT02866786

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

A Phase 4 study testing Metformin and ethinyl estradiol and cyproterone acetate in people with Polycystic Ovary Syndrome, run by S.C.B. Medical College and Hospital at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Metformin and ethinyl estradiol and cyproterone acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteIndia
Study dates
15 Aug 2016to 1 Aug 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Department of Obstetrics & Gynecology

    Cuttack, Odisha, 753007

Other trials in India

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Metformin, ethinyl estradiol and cyproterone acetate
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

  • ethinyl estradiol and cyproterone acetateDrug

    Oral Contraceptive Pill

Study groups in NCT02866786
Study groupRoleWhat they receive
OCP only armActive comparatorOCP 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.
Receives: Drug: ethinyl estradiol and cyproterone acetate
Metformin armActive comparatorMetformin 500mg bid in morning and evening after meals to be taken for 6 months.
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

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

    Measured: 6 months

  3. Change in weight as measured in kg

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  6. Change in waist-to-hip ratio

    Measured: 6 months

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

    Measured: 6 months

Secondary outcomes (16)

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

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  6. Change in Free androgen Index (FAI)

    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.

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

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

    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

    Measured: 6 months

  10. Ovarian Stromal artery Pulsatility index

    Measured: 6 months

  11. Ovarian Stromal artery Resistivity index

    Measured: 6 months

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

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

    Measured: 6 months

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

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

    Measured: 6 months

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

    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

    Measured: 6 months

  15. Change in Endometrial thickness (in mm)

    Measured: 6 months

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

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start15 Aug 2016
  3. Primary completion20 Apr 2017
  4. Study completion1 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866786
Sponsor's protocol ID
OG/2016/13
Status last verified
Apr 2018
First submitted
4 Aug 2016
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin and ethinyl estradiol and cyproterone acetate in people with Polycystic Ovary Syndrome, run by S.C.B. Medical College and Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in menstrual cycle pattern (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.

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