- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04287205
The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis
March 16, 2020 updated by: Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
This study aimed to assess the effects of dydrogesterone on sexual function in women with endometriosis using Female Function Sexual Index (FSFI).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sexual dysfunction is an important outcome for patients with endometriosis.
In this study, we compare the fsfi (female sexual function index) questions and the scores before and after dydrogesterone treatment in patients with endometriosis.
We aim to measure the effect of dydrogesterone in patients with endometriosis.
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
İ̇stanbul
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Istanbul, İ̇stanbul, Turkey, 34000
- Pinar Yalcin Bahat
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- no history of malignancies,
- normal findings at gynecological examinations and transvaginal ultrasonography
- normal uterine size, normal cervical smear results,
- patients not use any contraception methods in the last 6 months
Exclusion Criteria:
- with a history of systemic and/or psychiatric diseases,
- gynecological pathologies (myoma uteri, endometriosis, uterine anomalies, existing genital infections)
- pelvic organ prolapse
- pelvic surgeries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: women with endometriosis
|
79 women, aged between 18 and 45 years, who were examined at our tertiary gynecology outpatient clinic between April 2019 and March 2020, with surgically diagnosed endometriosis, were included in this study.
They received a treatment with 5 mg dydrogesterone administered orally twice daily for 21 days; from the 5th to 25th day of each menstrual cycle, for a total of 6 months.
They were evaluated pre- and posttreatment in terms of their age, parity, and body mass index (BMI).
Female Function Sexual Index (FSFI) and visual analogue scale (VAS) scores were recorded pre- and posttreatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of Dydrogesterone on Sexual Function
Time Frame: 6 months
|
In this study, we compare the fsfi(female sexual function index) questions and the scores before and after dihydrogestreone treatment in patients with endometriosis.
We aim to measure the effect of dihydrogesterone in patients with endometriosis.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of Dydrogesterone on Sexual Function in women with endometrioma
Time Frame: 6 months
|
In this study, we compare the fsfi(female sexual function index) questions and the scores before and after dihydrogestreone treatment in patients with endometriosis.
We aim to measure the effect of dihydrogesterone in patients with endometriosis.(with and without endometrioma)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2019
Primary Completion (Actual)
February 27, 2020
Study Completion (Actual)
March 3, 2020
Study Registration Dates
First Submitted
February 23, 2020
First Submitted That Met QC Criteria
February 25, 2020
First Posted (Actual)
February 27, 2020
Study Record Updates
Last Update Posted (Actual)
March 18, 2020
Last Update Submitted That Met QC Criteria
March 16, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- endo-fsfi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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