Impact of Hormone Replacement Therapy on Sexual Quality of Life in Women with Premature Ovarian Failure
Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy
This study is testing whether hormone replacement therapy can improve sexual quality of life for women with premature ovarian failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05890417 on ClinicalTrials.gov |
What this trial studies
This study evaluates how hormone replacement therapy (HRT) affects the sexual quality of life in women diagnosed with premature ovarian insufficiency (POI). It utilizes the Female Sexual Function Index (FSFI) scale to assess changes in sexual function before and after HRT. The research aims to provide insights into the effectiveness of HRT in alleviating sexual disorders associated with POI, which can significantly impact the quality of life. By documenting these changes, the study seeks to enhance patient adherence to treatment and inform healthcare professionals about the benefits of HRT.
Who should consider this trial
Good fit: Ideal candidates are women under 40 with a confirmed diagnosis of premature ovarian insufficiency who have not yet received hormonal treatment.
Not a fit: Patients with contraindications to hormonal treatment or those unable to understand the study's implications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sexual quality of life for women with POI through effective hormone replacement therapy.
How similar studies have performed: Previous studies have shown that hormone replacement therapy can improve sexual function in women with POI, but this specific approach of assessing changes before and after treatment is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux
- CHU Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Valerie Bernard, MD
- Email: valerie.bernard@chu-bordeaux.fr
- Phone: -335 56 79 56 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.