The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis

NCT04287205 | Completed

• 1 other identifier: endo-fsfi
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometriosis; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Effect of Dydrogesterone on Sexual Function in women with endometrioma

  6 months

Study Arms (1)

women with endometriosis

EXPERIMENTAL

Drug: Dydrogesterone

Interventions

Dydrogesterone DRUG

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

women with endometriosis

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• with a history of systemic and/or psychiatric diseases,
• gynecological pathologies (myoma uteri, endometriosis, uterine anomalies, existing genital infections)
• pelvic organ prolapse
• pelvic surgeries

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometriosis; Sexual Dysfunction, Physiological

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 27, 2020
• Study Start: April 20, 2019
• Primary Completion: February 27, 2020
• Study Completion: March 3, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)