Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome

NCT ID: NCT06834594

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Turner Syndrome Primary Ovarian Insufficiency (Poi)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequential progesterone supplementation

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

Group Type ACTIVE_COMPARATOR

Micronized progesterone 200 MG

Intervention Type DRUG

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

Continuous progesterone supplementation:

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

Group Type ACTIVE_COMPARATOR

Micronized Progesterone 100 MG

Intervention Type DRUG

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

Interventions

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Micronized progesterone 200 MG

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

Intervention Type DRUG

Micronized Progesterone 100 MG

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

Intervention Type DRUG

Other Intervention Names

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Sequential Continuous

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Kansas City

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Allie Ranallo

Role: CONTACT

+1-816-394-7534

Andrea Manlove

Role: CONTACT

+1-816-731-7326

Facility Contacts

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Allie Ranallo

Role: primary

816-394-2574

Andrea Manlove

Role: backup

+1-816-731-7326

References

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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.

Reference Type BACKGROUND
PMID: 38748847 (View on PubMed)

Panay 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.

Reference Type BACKGROUND
PMID: 39660328 (View on PubMed)

Dowlut-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.

Reference Type BACKGROUND
PMID: 37094554 (View on PubMed)

Dowlut-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.

Reference Type BACKGROUND
PMID: 35272055 (View on PubMed)

Other Identifiers

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STUDY00003252

Identifier Type: -

Identifier Source: org_study_id

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