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

NCT05890417 | Recruiting

• 1 other identifier: CHUBX 2023/04
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Conditions

Premature Ovarian Failure

Keywords

premature ovarian insufficiency; sexuality; quality of life

Outcome Measures

Primary Outcomes (1)

• FSFI questionnaire score

  This is a self-assessment questionnaire with 19 items. It considers 6 domains of female sexuality: desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items) and pain (3 items). The items are rated on a 0 or 1 to 5 point scale (low score of 0-1 to high score of 5) to determine a raw score per domain. Then, the score for each domain is multiplied by a standardised coefficient to arrive at a total score between 2 and 36. The cut-off point for differentiating between women with and without sexual problems is 26.55; a lower score reflects the existence of sexual problems.

  Month 6

Secondary Outcomes (2)

• FSFI score according to the aetiology and to the mode of administration of hormonal treatment

  Baseline, Month 6

• WHOQOL-BREF score

  Baseline, Month 6

Study Arms (1)

Questionnaires

EXPERIMENTAL

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.

Other: questionnaire

Interventions

questionnaire 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

Questionnaires

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Sexuality

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Valerie Bernard, MD

CONTACT

-335 56 79 56 79; valerie.bernard@chu-bordeaux.fr

Lise Branet, MD

CONTACT

lise.branet@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 6, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)