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New treatment option for Premature Ovarian Insufficiency
Official title Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
ClinicalTrials.gov ID: NCT06851754
What this study is testing
What is Progesterone?
Progesterone is an investigational medicine, given as a pill taken by mouth, 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
- Background: Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 19, women only. Healthy volunteers may be eligible.
You may be able to join if
- for POI Participants To be eligible to participate in this study, an individual must meet all the following criteria:
- Individuals aged 11-19 years, inclusive, at the time of enrollment.
- Diagnosis of premature ovarian insufficiency.
- Documentation of one elevated serum FSH measurement greater than the testing laboratory's upper reference range (for age/Tanner stage).
- Identify as female (i.e., sex assigned at birth)
You likely can't join if
- Male participants are excluded from both study groups (POI and Healthy Volunteers) as POI affects only the female reproductive system, while pregnant...
- POI in the setting of Turner syndrome.
- Patients who screened positive for celiac disease.
- Receipt of any medications including HRT determined by the investigator to affect bone metabolism 3 months prior to enrollment.
- Any medical condition determined by the investigator to affect bone health will be excluded.
- Presence of a medical, psychiatric, or social condition which, in the opinion of the investigator, would place undue burden on the subject, NIH...
See the full eligibility criteria
- for POI Participants To be eligible to participate in this study, an individual must meet all the following criteria:
- Individuals aged 11-19 years, inclusive, at the time of enrollment.
- Diagnosis of premature ovarian insufficiency.
- Documentation of one elevated serum FSH measurement greater than the testing laboratory's upper reference range (for age/Tanner stage).
- Identify as female (i.e., sex assigned at birth)
- Negative pregnancy test. for Healthy Volunteers:
- Individuals aged 11-19 years.
- Identify as female (i.e., sex assigned at birth)
- Negative pregnancy test.
- Absence of known chronic disease
- Male participants are excluded from both study groups (POI and Healthy Volunteers) as POI affects only the female reproductive system, while pregnant participants are not eligible to have DXA or HRpQCT imaging for...
- POI in the setting of Turner syndrome.
- Patients who screened positive for celiac disease.
- Receipt of any medications including HRT determined by the investigator to affect bone metabolism 3 months prior to enrollment.
- Any medical condition determined by the investigator to affect bone health will be excluded.
- Presence of a medical, psychiatric, or social condition which, in the opinion of the investigator, would place undue burden on the subject, NIH resources, or increase risk of participation.
- Report of sexual activity but refusal to use a copper intrauterine device or double barrier forms of contraception during the study. Exclusion Criteria for Healthy Volunteers: For healthy volunteers, all exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
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, 11 years to 19 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. 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.