Turner Syndrome, Primary Ovarian Insufficiency (Poi)
Conditions
Keywords
Turner syndrome, Primary ovarian insufficiency, Hormone replacement therapy
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).
Interventions
Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle
DRUGMicronized Progesterone 100 MG
Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 20 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC) | From enrollment to end of treatment at day 90. | 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
| Measure | Time frame | Description |
|---|---|---|
| Menstrual distress questionnaire (MEDI-Q) | From enrollment to end of treatment at day 90. | 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. | On study day 90 +/- 14 days. | Endometrial thickness measured by transabdominal pelvic ultrasound. |
Countries
United States
Contacts
Primary ContactAllie Ranallo
Backup ContactAndrea Manlove
Outcome results
None listed