The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis

Endometriosis Clinical Trial

Official title:

The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287205
• Other study ID #: endo-fsfi
• Status: Completed
• Phase: N/A
• Start date: April 20, 2019
• Est. completion date: March 3, 2020

Study information

• Verified date: March 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to assess the effects of dydrogesterone on sexual function in women with endometriosis using Female Function Sexual Index (FSFI).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 3, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Sexual Dysfunction

Intervention

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

Locations

Country	Name	City	State
Turkey	Pinar Yalcin Bahat	Istanbul	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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)	6 months