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

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Children's Mercy Hospital Kansas City
Study ID
NCT06834594
Phase
PHASE4
Status
Recruiting
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Conditions

  • Primary Ovarian Insufficiency (Poi)
  • Turner Syndrome

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Micronized progesterone 200 MG — DRUG
    Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle
  • Micronized Progesterone 100 MG — DRUG
    Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.

Study Details

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).

Key Dates

Start date
Jul 31, 2025
Status verified
Aug 2025
Primary completion
Jul 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Sequential progesterone supplementation
    Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle.
  • Active Comparator: Continuous progesterone supplementation:
    Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Mercy HospitalKansas CityMissouri64108
Allie Ranallo
[email protected]
816-394-2574
Andrea Manlove
[email protected]
+1-816-731-7326
Tazim Dowlut-McElroy, M.D., M.S. (PRINCIPAL_INVESTIGATOR)
Madeline Ross, M.D. (SUB_INVESTIGATOR)
Joseph Cernich, M.D. (SUB_INVESTIGATOR)

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By research site
Children's Mercy Hospital· Kansas City, MO

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