The Effect of Dydrogesterone on Sexual Function in Women With Endometriosis

NCT ID: NCT04287205

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-20

Study Completion Date

2020-03-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Endometriosis Sexual Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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women with endometriosis

Group Type EXPERIMENTAL

Dydrogesterone

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pınar Yalcin bahat

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pinar Yalcin Bahat

Istanbul, İ̇stanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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endo-fsfi

Identifier Type: -

Identifier Source: org_study_id

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