The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04287205

Collaborator

(none)

Enrollment

Location

Arm

10.4

Actual Duration (Months)

7.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Sexual Dysfunction	Drug: Dydrogesterone	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis

Actual Study Start Date :

Apr 20, 2019

Actual Primary Completion Date :

Feb 27, 2020

Actual Study Completion Date :

Mar 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: women with endometriosis	Drug: Dydrogesterone 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

Arm

Intervention/Treatment

Experimental: women with endometriosis

Drug: Dydrogesterone

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

Outcome Measures

Primary Outcome Measures

The Effect of Dydrogesterone on Sexual Function [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.

Secondary Outcome Measures

The Effect of Dydrogesterone on Sexual Function in women with endometrioma [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinar Yalcin Bahat	Istanbul	İ̇stanbul	Turkey	34000

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pınar Yalcin bahat, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04287205

Other Study ID Numbers:

endo-fsfi

First Posted:

Feb 27, 2020

Last Update Posted:

Mar 18, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Dydrogesterone

Study Results

No Results Posted as of Mar 18, 2020