Back to resultsThe Effect of Dydrogesterone on Sexual Function in Women With Endometriosis
Primary Purpose
Endometriosis, Sexual Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dydrogesterone
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
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
Sites / Locations
- Pinar Yalcin Bahat
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
women with endometriosis
Arm Description
Outcomes
Primary Outcome Measures
The Effect of Dydrogesterone on Sexual Function
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.
Secondary Outcome Measures
The Effect of Dydrogesterone on Sexual Function in women with endometrioma
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)
Full Information
NCT ID
NCT04287205
First Posted
February 23, 2020
Last Updated
March 16, 2020
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04287205
Brief Title
The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis
Official Title
The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aimed to assess the effects of dydrogesterone on sexual function in women with endometriosis using Female Function Sexual Index (FSFI).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Sexual Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
women with endometriosis
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone
Intervention Description
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
Primary Outcome Measure Information:
Title
The Effect of Dydrogesterone on Sexual Function
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The Effect of Dydrogesterone on Sexual Function in women with endometrioma
Description
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)
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pinar Yalcin Bahat
City
Istanbul
State/Province
İ̇stanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis
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