NCT02744131

Brief Summary

Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E\&P cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS( polycystic ovary syndrome)women from India. Intervention: Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference, Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks), Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid Profile, FAsting blood sugar \& 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25- hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays) Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood sugar); GTT(glucose tolerance test)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

2.3 years

First QC Date

March 20, 2016

Last Update Submit

February 1, 2018

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSMetforminOCPmetabolic parameters

Outcome Measures

Primary Outcomes (8)

  • Improvements in Menstrual cycle in women with polycystic ovary syndrome.

    To compare improvement in Menstrual cycle. Women will be required to maintain a menstrual calendar for the duration of the study and asked to fill a questionnaire before and after study duration.The questionnaire will cover menstrual cycle dates, duration and amount. Interpreting the answered will help in assessing improvement in menstrual pattern.

    Six months

  • Improvement in hirsutism

    FG scores before and after treatment will be compared between the two arms. Modified Ferriman and Gallwey visual score will be used by a nurse to assess before and after the study period.

    six months

  • Improvement in acne score

    Acne scores before and after treatment will be compared between the two arms. Visual assessment of acne using "mild/moderate/severe " grades will be assessed before and after study by a physician.

    Six months

  • Weight loss following treatment

    Weight loss will be compared between the two arms following 6 months of treatment

    6months

  • Reduction in total testosterones

    Reduction in total testosterones, signifying biochemical hyperandrogenemia, will be compared between the two groups following 6 months treatment.

    6months

  • Reduction in serum fasting insulin

    Reduction in insulin levels following treatment will be compared between the two arms

    6 months

  • Improvements in lipid profile

    Any improvement in triglycerides and HDLc (high density lipoprotein c) will be compared between the two groups after 6 months of treatment

    6months

  • Improvement in glucose tolerance

    75grams 2 hour glucose challenge test results will be compared pre and post treatment between the two groups

    6months

Study Arms (2)

OCP

ACTIVE COMPARATOR

Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate.

Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate

Metformin

ACTIVE COMPARATOR

Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily.

Drug: Metformin 1500mgs per day

Interventions

Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetateDRUG
OCP
Metformin 1500mgs per dayDRUG
Metformin

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • PCOS Women diagnosed by Rotterdam criteria
  • Age \> 16 or menarche of at least 2 yr upto age 40.
  • Diagnosed by Rotterdam Anovulation F.G. Score ≥ 8 or Total testosterone ≥ 40 ngms/dl ovarian volume ≥ 10 cc BMI\>23
  • Women not attempting pregnancy at present.

You may not qualify if:

  • PCOS Women with BMI ≤ 23
  • Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic
  • Known diabetic or hypertension .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KAR clinic and hospital pvt ltd

Bhubaneswar, Odisha, 751001, India

RECRUITING

Related Publications (3)

  • Kar S. Clomiphene citrate or letrozole as first-line ovulation induction drug in infertile PCOS women: A prospective randomized trial. J Hum Reprod Sci. 2012 Sep;5(3):262-5. doi: 10.4103/0974-1208.106338.

    PMID: 23531705BACKGROUND

  • Kar S, Sanchita S. Clomiphene citrate, metformin or a combination of both as the first line ovulation induction drug for Asian Indian women with polycystic ovarian syndrome: A randomized controlled trial. J Hum Reprod Sci. 2015 Oct-Dec;8(4):197-201. doi: 10.4103/0974-1208.170373.

    PMID: 26752854BACKGROUND

  • Kumar P, Nawani N, Malhotra N, Malhotra J, Patil M, Jayakrishnan K, Kar S, Jirge PR, Mahajan N. Assisted reproduction in polycystic ovarian disease: A multicentric trial in India. J Hum Reprod Sci. 2013 Jan;6(1):49-53. doi: 10.4103/0974-1208.112382.

    PMID: 23869152BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Contraceptives, OralCyproterone Acetate

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesCyproteronePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Central Study Contacts

Sujata Kar, MD

CONTACT

919437824163suju2463@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2016

First Posted

April 20, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2019

Last Updated

February 5, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Locations

IN(1)