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

Phase 4

Not yet recruiting

• Conditions: Turner Syndrome; Primary Ovarian Insufficiency (Poi)
• Interventions: Drug: Micronized progesterone 200 MG; Drug: Micronized Progesterone 100 MG

• Registration Number: NCT06834594
• Lead Sponsor: Children's Mercy Hospital Kansas City

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Study Start: 2025-05-13
• Primary Completion: 2026-04-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential progesterone supplementation	Micronized progesterone 200 MG	Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle.
Continuous progesterone supplementation:	Micronized Progesterone 100 MG	Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.

Primary Outcome Measures

Name	Time	Method
Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC)	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

Secondary Outcome Measures

Name	Time	Method
Menstrual distress questionnaire (MEDI-Q)	From enrollment to end of treatment at day 90.	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
Endometrial thickness.	On study day 90 +/- 14 days.	Endometrial thickness measured by transabdominal pelvic ultrasound.

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States