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

Children's Mercy Hospital Kansas City

Status and phase: Enrolling; Phase 4

Conditions: Turner Syndrome; Primary Ovarian Insufficiency (Poi)

Treatments: Drug: Micronized progesterone 200 MG; Drug: Micronized Progesterone 100 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06834594

STUDY00003252

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: Female

Ages: 12 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sequential progesterone supplementation

Active Comparator group

Description:

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

Treatment:

Drug: Micronized progesterone 200 MG

Continuous progesterone supplementation:

Active Comparator group

Description:

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

Treatment:

Drug: Micronized Progesterone 100 MG