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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Micronized progesterone 200 MG
DrugOral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle
Micronized Progesterone 100 MG
DrugOral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
Endometrial thickness.
Endometrial thickness measured by transabdominal pelvic ultrasound.
Sponsors and contacts
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