NCT04831151

Brief Summary

The aim of this study is to determine the effect of the treatment of polycystic ovary syndrome with two different oral contraceptives that contain cyproterone acetate and drospirenone

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
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration 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

Study Start

First participant enrolled

March 1, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

March 28, 2021

Last Update Submit

May 18, 2022

Conditions

Polycystic Ovary Syndrome

Keywords

hirsutismcombined oral contraceptivesamenorrhea

Outcome Measures

Primary Outcomes (1)

  • Metabolomics

    measured by H1 nuclear magnetic resonance spectroscopy

    3 months

Secondary Outcomes (5)

  • hirsutism score

    3 months

  • fasting serum insulin levels

    3 months

  • low density lipoprotein

    3 months

  • body mass index

    3 months

  • clinical findings

    3 months

Study Arms (2)

Drospirenone group: 0,03 mg ethinylestradiol + 3 mg drospirenone

ACTIVE COMPARATOR

generic name:yasmin dosage form:oral dosage: 0,03 mg ethinylestradiol + 3 mg drospirenone frequency: once a day duration: 3 months

Drug: Yasmin

cyproterone acetate group: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate

ACTIVE COMPARATOR

generic name:diane 35 dosage form:oral dosage: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate frequency: once a day duration: 3 months

Drug: Diane-35

Interventions

YasminDRUG

Yasmin: 0,03 mg ethinylestradiol + 3 mg drospirenone

Drospirenone group: 0,03 mg ethinylestradiol + 3 mg drospirenone
Diane-35DRUG

Diane 35: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate

cyproterone acetate group: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate

Eligibility Criteria

Age15 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients who are diagnosed with polycystic ovary syndrome according to Rotterdam criteria and who do not have any additional chronic systemic disease

You may not qualify if:

  • The presence of any diseases that cause hormonal disorders and any chronic systemic diseases, the patients who are already under any treatment for polycystic ovary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeHirsutismAmenorrhea

Interventions

drospirenone and ethinyl estradiol combinationCyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and SymptomsMenstruation DisturbancesPathologic Processes

Central Study Contacts

Senem Arda Düz, Asisstant professor

CONTACT

+905332776401senem_arda@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 28, 2021

First Posted

April 5, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Locations

TU(1)