Micronized Progesterone for Turner Syndrome
(BOOST Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have a levonorgestrel-releasing intrauterine device or an etonogestrel arm implant, you cannot participate.
What data supports the effectiveness of the drug micronized progesterone for Turner Syndrome?
Is micronized progesterone safe for use in humans?
Micronized progesterone is generally considered safe and well-tolerated for various conditions, but some studies have reported liver-related side effects, such as increased liver enzymes and pruritus (itching), especially at high doses. It is important to monitor liver function during treatment, and further research is needed to fully establish its safety profile.13678
How does the drug micronized progesterone differ from other treatments for Turner Syndrome?
Micronized progesterone is unique because it is a natural form of the hormone progesterone, which is identical to what the body produces, and it is taken orally, making it more convenient than other forms like injections or vaginal applications. Unlike synthetic progestins, it has fewer metabolic and vascular side effects, and it is well-tolerated with minimal side effects such as mild drowsiness.39101112
What is the purpose of this trial?
This is a single-site open label non-randomized study comparing effects of sequential versus continuous use of progesterone supplementation amongst Turner Syndrome (TS) patients with primary ovarian insufficiency (POI) prescribed hormone replacement therapy (HRT).
Research Team
Tazim Dowlut-McElroy, M.D., M.S.
Principal Investigator
Children's Mercy Kansas City
Eligibility Criteria
This trial is for adolescent females with Turner Syndrome who have primary ovarian insufficiency and are on hormone replacement therapy. It's not suitable for those with certain medical conditions that could interfere with the study or if they're unable to comply with the treatment plan.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either sequential or continuous progesterone supplementation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Micronized Progesterone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas City
Lead Sponsor