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

NCT06834594 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00003252
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Turner Syndrome; Primary Ovarian Insufficiency (Poi)

Keywords

Turner syndrome; Primary ovarian insufficiency; Hormone replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to end of treatment at day 90.

Secondary Outcomes (2)

• Menstrual distress questionnaire (MEDI-Q)

  From enrollment to end of treatment at day 90.

• Endometrial thickness.

  On study day 90 +/- 14 days.

Study Arms (2)

Sequential progesterone supplementation

ACTIVE COMPARATOR

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

Drug: Micronized progesterone 200 MG

Continuous progesterone supplementation:

ACTIVE COMPARATOR

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

Drug: Micronized Progesterone 100 MG

Interventions

Micronized progesterone 200 MG DRUG

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

Also known as: Sequential

Sequential progesterone supplementation

Micronized Progesterone 100 MG DRUG

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

Also known as: Continuous

Continuous progesterone supplementation:

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 38748847 BACKGROUND

• 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.

  PMID: 39660328 BACKGROUND

• 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.

  PMID: 37094554 BACKGROUND

• 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.

  PMID: 35272055 BACKGROUND

MeSH Terms

Conditions

Turner Syndrome; Primary Ovarian Insufficiency

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Tazim Dowlut-McElroy, M.D., M.S.

  Children's Mercy Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allie Ranallo

CONTACT

+1-816-394-7534; alranallo@cmh.edu

Andrea Manlove

CONTACT

+1-816-731-7326; almanlove@cmh.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)