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New treatment option for Premature Ovarian Insufficiency
Official title Ventricular Repolarization in Patients With Premature Ovarian Insufficiency (QTIOP)
ClinicalTrials.gov ID: NCT04167033
What this study is testing
What is Hormone replacement therapy:effect on ventricular repolarization?
Hormone replacement therapy:effect on ventricular repolarization is an investigational medicine, being studied as a potential treatment for premature ovarian insufficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ventricular repolarization, measured by corrected QT interval (QTc), is influenced by sex hormones. A QTc above 460msec predisposes to the risk of "torsades-de-pointes"(TdP).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- Patients with POI
- Patient aged 18 to 41 years
- Patient with POI diagnostic criteria (FSH \>25UI/l twice at intervals of a few weeks) with amenorrhea
- No hormone treatment interacting with the gonadotropic axis for at least one month before inclusion
- Patient who has signed informed consent
You likely can't join if
- Patients with POI
- Patient on HRT during the 1st evaluation
- Pregnant or breastfeeding woman
- Treatment regimen known to lengthen QT or act on ventricular repolarization
- Cardiac history in particular cardiac rhythm disorder
- Diabetes
See the full eligibility criteria
- Patients with POI
- Patient aged 18 to 41 years
- Patient with POI diagnostic criteria (FSH \>25UI/l twice at intervals of a few weeks) with amenorrhea
- No hormone treatment interacting with the gonadotropic axis for at least one month before inclusion
- Patient who has signed informed consent
- Patient affiliated to a social security system Healthy volunteers (including POI control group)
- Healthy women, aged 18 to 40 years, age-matched (+/- 5 years), and by BMI class (BMI\ 40) compared to women with BPI
- Women with regular cycles of 26 to 32 days
- Women who has signed an informed consent form
- Patient affiliated to a social security system
- Patients with POI
- Patient on HRT during the 1st evaluation
- Pregnant or breastfeeding woman
- Treatment regimen known to lengthen QT or act on ventricular repolarization
- Cardiac history in particular cardiac rhythm disorder
- Diabetes
- Patient on AME (unless derogation from affiliation),
- Severe renal insufficiency (MDRD \<30ml/min/m²) Healthy volunteers (including POI control group)
- Diabetes or any chronic disease (including cardiovascular and endocrine)
- Pregnant or breastfeeding woman
- Hormonal contraceptive treatment in progress or stopped less than 3 months ago
- Chronic treatment affecting the duration of QTc
- Woman under AME (unless affiliation derogation)
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.