Micronized Progesterone for Turner Syndrome

(BOOST Trial)

Overseen By Andrea Manlove

Age: < 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Children's Mercy Hospital Kansas City

Must be taking: Estradiol

Must not be taking: Levonorgestrel, Etonogestrel, Medroxyprogesterone

Disqualifiers: Sexual activity, Non-English/Spanish, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different schedules for taking micronized progesterone, a form of hormone therapy, might benefit women with Turner Syndrome who also have primary ovarian insufficiency, a condition where the ovaries don't function properly. The study compares taking progesterone continuously every day to taking it only part of the month. It aims to determine the most effective hormone therapy support for these women. Women diagnosed with Turner Syndrome and primary ovarian insufficiency who are already on hormone replacement therapy may be suitable candidates for this study. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for micronized progesterone?

Research has shown that micronized progesterone is generally safe and well-tolerated, with a good safety record, particularly concerning breast cancer risk. However, some reports mention possible liver-related side effects, so awareness of this is important.

This treatment is widely used for various conditions, including Turner Syndrome, due to its benefits. Its study in a Phase 4 trial indicates that extensive safety information is already available. Phase 4 trials typically mean a treatment has approval for some use, providing strong evidence of its safety.

In summary, while it is mostly well-tolerated, be mindful of potential liver-related issues. Always discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using micronized progesterone for Turner Syndrome because it offers a more natural hormone replacement option with potentially fewer side effects compared to synthetic alternatives. Unlike traditional treatments that often use synthetic hormones, micronized progesterone is bioidentical, meaning it's chemically identical to the hormone produced naturally in the body, which can improve how the body metabolizes it. Additionally, the trial is exploring both continuous and sequential dosing strategies, which could provide more tailored treatment options based on individual needs and responses. This flexibility in administration might help optimize symptom management and improve quality of life for those with Turner Syndrome.

What evidence suggests that micronized progesterone might be an effective treatment for Turner Syndrome?

Research has shown that micronized progesterone is safe, effective, and well-tolerated for various women's health issues, including Turner Syndrome. In Turner Syndrome, it is often used with estrogen as part of hormone replacement therapy (HRT). This combination is crucial for managing symptoms because Turner Syndrome often leads to early ovarian failure. Micronized progesterone helps balance hormone levels, supporting bone health and reducing the risk of certain problems. In this trial, participants will receive either continuous or sequential progesterone supplementation. Although generally effective, long-term use has been linked to a higher risk of uterine cancer, making regular check-ups important. ^{2 3 5 6 7}

Who Is on the Research Team?

Tazim Dowlut-McElroy, M.D., M.S.

Principal Investigator

Children's Mercy Kansas City

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Continuous progesterone supplementation: Active Control 1 Intervention

Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.

Group II: Sequential progesterone supplementation Active Control 1 Intervention

Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle.

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral micronized progesterone. de Lignières, B.[2022]

Oral micronized progesterone effectively reproduces the natural hormone's anti-estrogenic and anti-mineralocorticoid effects at a daily dose of 200 mg, making it a viable option for various hormonal therapies.

This preparation has shown no adverse effects on lipid profiles, coagulation factors, or blood pressure, indicating its safety for use in postmenopausal therapy, premenstrual syndrome, and pregnancy maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral micronized progesterone. Bioavailability pharmacokinetics, pharmacological and therapeutic implications--a review. Sitruk-Ware, R., Bricaire, C., De Lignieres, B., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral administration of micronized progesterone: a review and more experience. McAuley, JW., Kroboth, FJ., Kroboth, PD.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micronized progesterone: a new option for women's health care. Wetzel, W.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9288983/

The Care of Adolescents and Young Adults with Turner ... The use of micronized progesterone in combination with estrogen for greater than 5 years has been associated with a 2-fold increase in endometrial cancer but ...

2. academic.oup.com academic.oup.com/jcem/article/103/5/1790/4844749

Estrogen Replacement in Turner Syndrome: Literature Review ... We reviewed the literature on estrogen replacement to induce puberty and minimize risks. Evidence supports starting with low-dose transdermal E2 and mimic.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1083318822001760

The Care of Adolescents and Young Adults with Turner ... A randomized control trial of very low-dose prepubertal estrogen supplementation showed improvement in growth velocity, memory, and executive function, but ...

4. withpower.com withpower.com/trial/phase-4-turner-syndrome-2-2025-5f3de

Micronized Progesterone for Turner Syndrome (BOOST Trial) Micronized progesterone has been shown to be safe, effective, and well-tolerated for various gynecologic conditions, and it is considered an attractive ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3760009/

The Patient with Turner Syndrome: Puberty and Medical ... Transdermal estradiol and micronized progesterone are preferable for girls with TS who have an increased risk of VTE (37). Bone Health. Bone mineral density ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11294403/

Diagnostic and therapeutic use of oral micronized ... Micronized progesterone appears as a good therapeutic option because of its favorable safety profile, especially with regard to breast cancer ...

7. pedsendo.org pedsendo.org/wp-content/uploads/2025/04/TS-Family-guidelines-English-March-2025-Final.pdf

Clinical Care in Turner Syndrome Micronized crystalline progesterone (e.g., Prometrium® 100–200 mg) is preferred. ... For safety, women with TS undergoing IVF should only have one embryo ...