40 Participants Needed

Micronized Progesterone for Turner Syndrome

(BOOST Trial)

AR
AM
Overseen ByAndrea Manlove
Age: < 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Children's Mercy Hospital Kansas City
Must be taking: Estradiol
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

Micronized progesterone has been shown to be safe, effective, and well-tolerated for various gynecologic conditions, and it is considered an attractive alternative to synthetic progestins due to its better absorption and fewer side effects.12345

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

TD

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

I have Turner Syndrome and my ovaries are not functioning properly.
I am taking estrogen replacement therapy as per official guidelines.
I have started my menstrual periods.

Exclusion Criteria

I have received a depot medroxyprogesterone shot within the last year.
I am willing to discuss my sexual activity and use contraception.
I use a hormonal IUD or arm implant for birth control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sequential or continuous progesterone supplementation

12 weeks
Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • Micronized Progesterone
Trial Overview The study is examining how different dosages of micronized progesterone (100 MG and 200 MG) affect bleeding patterns when taken either sequentially or continuously by patients as part of their hormone replacement therapy.
Participant Groups
2Treatment groups
Active Control
Group I: Continuous progesterone supplementation:Active Control1 Intervention
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Group II: Sequential progesterone supplementationActive Control1 Intervention
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials
261
Recruited
941,000+

Findings from Research

Oral micronized progesterone (MP) is a newly FDA-approved treatment that offers a safer and more effective alternative to traditional synthetic progestational agents, which often have adverse effects.
The article highlights the importance of individualized treatment plans and patient compliance, as demonstrated through five case studies, to achieve the best therapeutic outcomes with MP.
Micronized progesterone: a new option for women's health care.Wetzel, W.[2013]
A single oral dose of 300 mg micronized progesterone in eight healthy postmenopausal women showed effective absorption, achieving serum concentrations that mimic natural luteal phase levels.
The study found that absorption of micronized progesterone varied significantly among individuals and increased with age, suggesting it may be a promising alternative to synthetic progestins without negatively affecting lipoprotein profiles.
Oral administration of micronized progesterone: a review and more experience.McAuley, JW., Kroboth, FJ., Kroboth, PD.[2013]
Oral micronized progesterone is recommended over synthetic progestins for women using estrogen therapy, as it minimizes the risk of endometrial hyperplasia and cancer while avoiding the metabolic and vascular side effects associated with synthetic options.
This formulation has been widely used in Europe since 1980, is well tolerated with minimal side effects, and has established long-term endometrial protection, making it a preferred choice for nonhysterectomized postmenopausal women.
Oral micronized progesterone.de Lignières, B.[2022]

References

Micronized progesterone: a new option for women's health care. [2013]
Progesterone levels on the day of embryo transfer using a single pessary of 400mg of vaginal progesterone vs. 200mg x2 pessaries in hormonal replacement cycles. [2023]
[Effects of micronized natural progesterone on the liver during the third trimester of pregnancy]. [2013]
Oral versus Vaginal Micronized Progesterone for the Treatment of Threatened Miscarriage. [2022]
Oral administration of micronized progesterone: a review and more experience. [2013]
The use of micronised progesterone for menopausal hormone therapy, a clinical practice audit. [2017]
[Hepatic cytolysis caused by tocolytic treatment using micronized natural progesterone]. [2016]
Comparing the efficacy of vaginal micronized progesterone gel and capsule for prevention of preterm birth in singleton pregnancies with short cervical length at midtrimester: an indirect comparison meta-analysis. [2023]
Liver metabolism during treatment with estradiol and natural progesterone. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Oral micronized progesterone. [2022]
A prospective randomized multicentre study comparing vaginal progesterone gel and vaginal micronized progesterone tablets for luteal support after in vitro fertilization/intracytoplasmic sperm injection. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Oral micronized progesterone. Bioavailability pharmacokinetics, pharmacological and therapeutic implications--a review. [2019]
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