Turner SyndromePhase 4BOOSTNCT06834594
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
A Phase 4 study testing Micronized progesterone 200 MG and Micronized Progesterone 100 MG in people with Turner Syndrome and Primary Ovarian Insufficiency (Poi), run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 to 20 years, women only
- Conditions the study is for
- Turner Syndrome, Primary Ovarian Insufficiency (Poi)
- What is being tested?
- Micronized progesterone 200 MG and Micronized Progesterone 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2025to 31 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Turner Syndrome and Primary Ovarian Insufficiency.
- Prescribed adult dosing* of transdermal or oral estradiol for estrogen replacement therapy.
- Adult dosing of will be defined per published clinical practice guidelines from the 2023 International Turner Syndrome Meeting (i.e. 50-200μg/day of transdermal estradiol, or (i.e. 50-200μg/day of transdermal estradiol or 2-4mg/day oral estradiol).
- Have achieved menarche.
Who cannot join
- Disclosure of sexual activity and desire for contraception.
- Having a levonorgestrel-releasing intrauterine device or etonogestrel arm implant in place.
- Having received depot medroxyprogesterone within one year prior to study recruitment.
- Non-English or non-Spanish speaking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Allie Ranallo, +1-816-394-2574, alranallo@cmh.edu
Andrea Manlove, +1-816-731-7326, almanlove@cmh.edu
About this study
Official title: Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)
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).
- Being tested
- Micronized progesterone 200 MG, Micronized Progesterone 100 MG
- Keywords
- Turner syndrome, Primary ovarian insufficiency, Hormone replacement therapy
- Medical subject headings
- Turner Syndrome, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized progesterone 200 MGDrug
Also called Sequential
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle
Micronized Progesterone 100 MGDrug
Also called Continuous
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Sequential progesterone supplementation | Active comparator | Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle. Receives: Drug: Micronized progesterone 200 MG |
| Continuous progesterone supplementation: | Active comparator | Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle. Receives: Drug: Micronized Progesterone 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC)
PBAC is one of the most common scoring systems used in the literature to quantify menstrual blood loss (MBL) using a pictorial scoring system, with a higher score representing a larger MBL and a score >100 qualifying as heavy menstrual bleeding
Measured: From enrollment to end of treatment at day 90.
Secondary outcomes (2)
Menstrual distress questionnaire (MEDI-Q)
The Menstrual distress questionnaire (MEDI-Q) is a valid and reliable instrument for the assessment of menstrual distress and its impact on psychological well-being. This tool can be utilized in research and clinical settings to comprehensively investigate the impact of menstruation on various populations
Measured: From enrollment to end of treatment at day 90.
Endometrial thickness.
Endometrial thickness measured by transabdominal pelvic ultrasound.
Measured: On study day 90 +/- 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start31 Jul 2025
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Turner SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tazim Dowlut-McElroy, Children's Mercy Hospital Kansas City
- Investigators
- Tazim Dowlut-McElroy, M.D., M.S., Principal investigator, Children's Mercy Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834594
- Sponsor's protocol ID
- STUDY00003252
- Acronym
- BOOST
- Status last verified
- Jul 2026
- First submitted
- 14 Feb 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Protect confidentiality of individuals with this rare disease (Turner syndrome).
Publications
Gravholt CH, Andersen NH, Christin-Maitre S, Davis SM, Duijnhouwer A, Gawlik A, Maciel-Guerra AT, Gutmark-Little I, Fleischer K, Hong D, Klein KO, Prakash SK, Shankar RK, Sandberg DE, Sas TCJ, Skakkebaek A, Stochholm K, van der Velden JA; International Turner Syndrome Consensus Group; Backeljauw PF. Clinical practice guidelines for the care of girls and women with Turner syndrome. Eur J Endocrinol. 2024 Jun 5;190(6):G53-G151. doi: 10.1093/ejendo/lvae050.
PubMed 38748847Panay N, Anderson RA, Bennie A, Cedars M, Davies M, Ee C, Gravholt CH, Kalantaridou S, Kallen A, Kim KQ, Misrahi M, Mousa A, Nappi RE, Rocca WA, Ruan X, Teede H, Vermeulen N, Vogt E, Vincent AJ; ESHRE, ASRM, CREWHIRL, and IMS Guideline Group on POI. Evidence-based guideline: premature ovarian insufficiency. Hum Reprod Open. 2024 Dec 9;2024(4):hoae065. doi: 10.1093/hropen/hoae065. eCollection 2024.
PubMed 39660328Dowlut-McElroy T, Kanakatti Shankar R. Hormone Replacement Therapy after Pubertal Induction in Adolescents and Young Adults with Turner Syndrome: A Survey Study. Horm Res Paediatr. 2024;97(1):62-69. doi: 10.1159/000530724. Epub 2023 Apr 24.
PubMed 37094554Dowlut-McElroy T, Shankar RK. The Care of Adolescents and Young Adults with Turner Syndrome: A Pediatric and Adolescent Gynecology Perspective. J Pediatr Adolesc Gynecol. 2022 Aug;35(4):429-434. doi: 10.1016/j.jpag.2022.02.002. Epub 2022 Mar 8.
PubMed 35272055
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)
- ClinicalTrials.gov ID
- NCT06834594
- Acronym / sponsor ID
- BOOST / STUDY00003252
- Keywords
- Turner syndrome, Primary ovarian insufficiency, Hormone replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential progesterone supplementation | Active comparator | Drug: Micronized progesterone 200 MGOral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle. |
| Continuous progesterone supplementation: | Active comparator | Drug: Micronized Progesterone 100 MGOral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of Turner Syndrome and Primary Ovarian Insufficiency.
- Prescribed adult dosing* of transdermal or oral estradiol for estrogen replacement therapy.
- Adult dosing of will be defined per published clinical practice guidelines from the 2023 International Turner Syndrome Meeting (i.e. 50-200μg/day of transdermal estradiol, or (i.e. 50-200μg/day of transdermal estradiol or 2-4mg/day oral estradiol).
- Have achieved menarche.
Key exclusion criteria (4 listed)
- Disclosure of sexual activity and desire for contraception.
- Having a levonorgestrel-releasing intrauterine device or etonogestrel arm implant in place.
- Having received depot medroxyprogesterone within one year prior to study recruitment.
- Non-English or non-Spanish speaking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronized progesterone 200 MGAlso: SequentialOral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle | Drug | Sequential progesterone supplementation |
| Micronized Progesterone 100 MGAlso: ContinuousOral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle. | Drug | Continuous progesterone supplementation: |
Primary outcome
Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC)
Time frame: From enrollment to end of treatment at day 90.
PBAC is one of the most common scoring systems used in the literature to quantify menstrual blood loss (MBL) using a pictorial scoring system, with a higher score representing a larger MBL and a score >100 qualifying as heavy menstrual bleeding
2 secondary outcomes
Menstrual distress questionnaire (MEDI-Q)
Time frame: From enrollment to end of treatment at day 90.
Endometrial thickness.
Time frame: On study day 90 +/- 14 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 38748847Gravholt CH, Andersen NH, Christin-Maitre S, Davis SM, Duijnhouwer A, Gawlik A, Maciel-Guerra AT, Gutmark-Little I, Fleischer K, Hong D, Klein KO, Prakash SK, Shankar RK, Sandberg DE, Sas TCJ, Skakkebaek A, Stochholm K, van der Velden JA; International Turner Syndrome Consensus Group; Backeljauw PF. Clinical practice guidelines for the care of girls and women with Turner syndrome. Eur J Endocrinol. 2024 Jun 5;190(6):G53-G151. doi: 10.1093/ejendo/lvae050.
- Background: PubMed 39660328Panay N, Anderson RA, Bennie A, Cedars M, Davies M, Ee C, Gravholt CH, Kalantaridou S, Kallen A, Kim KQ, Misrahi M, Mousa A, Nappi RE, Rocca WA, Ruan X, Teede H, Vermeulen N, Vogt E, Vincent AJ; ESHRE, ASRM, CREWHIRL, and IMS Guideline Group on POI. Evidence-based guideline: premature ovarian insufficiency. Hum Reprod Open. 2024 Dec 9;2024(4):hoae065. doi: 10.1093/hropen/hoae065. eCollection 2024.
- Background: PubMed 37094554Dowlut-McElroy T, Kanakatti Shankar R. Hormone Replacement Therapy after Pubertal Induction in Adolescents and Young Adults with Turner Syndrome: A Survey Study. Horm Res Paediatr. 2024;97(1):62-69. doi: 10.1159/000530724. Epub 2023 Apr 24.
- Background: PubMed 35272055Dowlut-McElroy T, Shankar RK. The Care of Adolescents and Young Adults with Turner Syndrome: A Pediatric and Adolescent Gynecology Perspective. J Pediatr Adolesc Gynecol. 2022 Aug;35(4):429-434. doi: 10.1016/j.jpag.2022.02.002. Epub 2022 Mar 8.
- Individual participant dataSharing planned: No. Protect confidentiality of individuals with this rare disease (Turner syndrome).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tazim Dowlut-McElroy, M.D., M.S. principal investigator
Children's Mercy Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Micronized progesterone 200 MG and Micronized Progesterone 100 MG in people with Turner Syndrome and Primary Ovarian Insufficiency (Poi), run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allie Ranallo (+1-816-394-7534, alranallo@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC) (time frame: From enrollment to end of treatment at day 90.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834594, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.