Recruiting

Progesterone Comparison

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT06834594

Conditions

Turner Syndrome

Primary Ovarian Insufficiency (Poi)

Eligibility Criteria

Sex: Female

Age: 12 - 20

Healthy Volunteers: Not accepted

Interventions

Micronized progesterone 200 MG

Micronized Progesterone 100 MG

Study Details

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)

Study ID

NCT06834594

Start date

Jul 31, 2025

Status verified date

Jul, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 20

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Micronized progesterone 200 MG

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

Micronized Progesterone 100 MG

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 and Locations

Central contacts

Allie Ranallo

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

Andrea Manlove

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

Locations

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Allie Ranallo

+1-816-394-2574alranallo@cmh.edu

Andrea Manlove

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

Principal Investigator:

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

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Aug 25, 2026

Last verified

Jul, 2026

Keywords

  • Turner syndrome
  • Primary ovarian insufficiency
  • Hormone replacement therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-08-25.