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

University Hospital of Bordeaux

Status: Enrolling

Conditions: Premature Ovarian Failure

Treatments: Other: questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT05890417

CHUBX 2023/04

Details and patient eligibility

About

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

Full 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

Enrollment: 135 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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135 participants in 1 patient group

Questionnaires

Experimental group

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.

Treatment:

Other: questionnaire