Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy

NCT ID: NCT05890417

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2027-06-30

Brief Summary

The aim of this study is to evaluate the evolution of quality of sex life of women with POI after introduction hormone replacement therapy through the FSFI scale

Detailed Description

Premature ovarian failure (POI) is a pathology that affects about 1-2% of women before the age of 40. The resulting estrogen deficiency is the cause of multiple repercussions. Clinically, sexual disorders may appear in the short term, such as a decrease in libido, vaginal dryness, an increase in dyspareunia, resulting in less frequent sexual intercourse and less satisfaction with sexual life. The quality of life of these patients also appears to be reduced compared to women with normal ovarian reserve. A 2008 study showed that the sexual function of patients with POI treated with hormone replacement therapy (HRT) was normal but remained significantly lower than that of patients with normal ovarian function. However, no study has attempted to assess the evolution of the symptomatology of these patients before and after the introduction of HRT. Evidence of improvement in sexual disorders under treatment could be an additional argument to improve patient adherence and treatment compliance; as well as information for health professionals

Conditions

Premature Ovarian Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Questionnaires

Female Sexual Function Index (FSFI) and WHO Quality of Life-BREF (WHOQOL-BREF) questionnaires at baseline and at 6 months after starting hormone replacement therapy.

Group Type: EXPERIMENTAL

questionnaire

Intervention Type: OTHER

Female Sexual Function Index (FSFI) and WHO Quality of Life-BREF (WHOQOL-BREF) questionnaires at baseline and 6 months after starting hormone replacement therapy

Interventions

questionnaire

Female Sexual Function Index (FSFI) and WHO Quality of Life-BREF (WHOQOL-BREF) questionnaires at baseline and 6 months after starting hormone replacement therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• positive diagnosis of POI (amenorrhea > 4 months or spaniomenorrhea > 4 months and FSH > 25 IU/L checked twice, more than 4 weeks apart)
• absence of hormonal treatment,
• patient's oral consent,
• affiliated or beneficiary of health insurance

Exclusion Criteria

• contraindication to hormonal treatment (history of hormone-dependent cancer, history of ischemic arterial stroke),
• inability of the patient to understand the nature or risks or significance and implications of the clinical investigation,
• patient under legal protection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Bordeaux

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Valerie Bernard, MD

Role: CONTACT

valerie.bernard@chu-bordeaux.fr

-335 56 79 56 79

Lise Branet, MD

Role: CONTACT

lise.branet@chu-bordeaux.fr

Facility Contacts

Valérie Bernard, MD

Role: primary

valerie.bernard@chu-bordeaux.fr

+335 56 79 56 79

Other Identifiers

CHUBX 2023/04

Identifier Type: -

Identifier Source: org_study_id