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Completed

NCT Number: NCT04287205

The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Sexual Dysfunction Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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