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Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy (SEX-POInt)

Primary Purpose

Premature Ovarian Failure

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaire
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Ovarian Failure focused on measuring premature ovarian insufficiency, sexuality, quality of life

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU BordeauxRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Questionnaires

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

FSFI score according to the aetiology and to the mode of administration of hormonal treatment
FSFI score before and after 6 months of treatment according to the aetiology of Premature ovarian failure (POI) (idiopathic, genetic, iatrogenic, Turner syndrome) and according to the mode of administration of hormonal treatment
WHOQOL-BREF score
The WHOQOL-BREF questionnaire is a self-assessment questionnaire with 26 items and has been used to study the quality of life of patients with POI. The WHOQOL-BREF is the short version of the WHOQOL and addresses 4 domains of quality of life: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall quality of life and general health. The items are evaluated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw score per item. Next, the average score for each domain is calculated, resulting in an average domain score between 4 and 20. Finally, this average domain score is then multiplied by 4 to transform the domain score into a scaled score (comparable to the score used in the original WHOQOL-100), with a higher score indicating a better quality of life

Full Information

First Posted
May 25, 2023
Last Updated
July 27, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05890417
Brief Title
Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy
Acronym
SEX-POInt
Official Title
Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
Keywords
premature ovarian insufficiency, sexuality, quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Questionnaires
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
questionnaire
Intervention Description
Female Sexual Function Index (FSFI) and WHO Quality of Life-BREF (WHOQOL-BREF) questionnaires at baseline and 6 months after starting hormone replacement therapy
Primary Outcome Measure Information:
Title
FSFI questionnaire score
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
FSFI score according to the aetiology and to the mode of administration of hormonal treatment
Description
FSFI score before and after 6 months of treatment according to the aetiology of Premature ovarian failure (POI) (idiopathic, genetic, iatrogenic, Turner syndrome) and according to the mode of administration of hormonal treatment
Time Frame
Baseline, Month 6
Title
WHOQOL-BREF score
Description
The WHOQOL-BREF questionnaire is a self-assessment questionnaire with 26 items and has been used to study the quality of life of patients with POI. The WHOQOL-BREF is the short version of the WHOQOL and addresses 4 domains of quality of life: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall quality of life and general health. The items are evaluated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw score per item. Next, the average score for each domain is calculated, resulting in an average domain score between 4 and 20. Finally, this average domain score is then multiplied by 4 to transform the domain score into a scaled score (comparable to the score used in the original WHOQOL-100), with a higher score indicating a better quality of life
Time Frame
Baseline, Month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Bernard, MD
Phone
-335 56 79 56 79
Email
valerie.bernard@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Branet, MD
Email
lise.branet@chu-bordeaux.fr
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Bernard, MD
Phone
+335 56 79 56 79
Email
valerie.bernard@chu-bordeaux.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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