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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age12-20
SponsorChildren's Mercy Hospital Kansas City

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Turner Syndrome and Primary Ovarian Insufficiency.

Prescribed adult dosing* of transdermal or oral estradiol for estrogen replacement therapy.

Have achieved menarche.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Sequential progesterone supplementationActive comparator 1 intervention
Group B: Continuous progesterone supplementation:Active comparator 1 intervention

Trial outcomes

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

Time frame
From enrollment to end of treatment at day 90.

Secondary outcomes

1

Menstrual distress questionnaire (MEDI-Q)

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

Time frame
From enrollment to end of treatment at day 90.
2

Endometrial thickness.

Endometrial thickness measured by transabdominal pelvic ultrasound.

Time frame
On study day 90 +/- 14 days.

Other outcomes

Sponsors and contacts

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