Evidence-based guideline: premature ovarian insufficiency.
Nick Panay, Richard A Anderson, Amy Bennie...
https://pubmed.ncbi.nlm.nih.gov/39660328/Actively Recruiting
Led by Children's Mercy Hospital Kansas City · Updated on 2025-09-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effects of two different progesterone supplementation methods in adolescents and young women with Turner Syndrome who also have primary ovarian insufficiency and are prescribed hormone replacement therapy. This Phase 4, single-site, open-label, non-randomized study compares sequential versus continuous use of progesterone to understand differences in menstrual bleeding patterns. Participants receive either oral micronized progesterone 200 mg for the first 12 days of a 30 to 31-day cycle sequential supplementation or oral micronized progesterone 100 mg daily throughout the entire 30 to 31-day cycle continuous supplementation. Both regimens are studied over a 90-day treatment period. During the study, participants will track menstrual bleeding using the Pictorial Bleeding Assessment Chart, complete a menstrual distress questionnaire, and have endometrial thickness measured near the end of treatment. Researchers will assess these outcomes from enrollment through the 90-day treatment to understand how each progesterone regimen affects menstrual patterns and related symptoms.
CONDITIONS
Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
A
Allie Ranallo
A
Andrea Manlove
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Children's Mercy Hospital Kansas City
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Sequential progesterone | Continuous progesterone |
|---|---|---|
| What it is | Micronized progesterone 200 mg taken orally for approximately 10–12 days per 30‑ to 31‑day estrogen cycle | Oral micronized progesterone 100 mg taken daily throughout the 30‑ to 31‑day estrogen cycle |
| Role in trial | Investigational arm assessing bleeding when progesterone is given only part of the cycle | Investigational comparator arm assessing bleeding during continuous daily progesterone |
| Primary use | Protect endometrium during estrogen replacement and assess menstrual bleeding patterns | Protect endometrium during estrogen replacement and assess menstrual bleeding patterns |
| How it is given | Taken orally for the first 10–12 days of each 30‑ to 31‑day estrogen cycle | Taken orally each day throughout the full 30‑ to 31‑day estrogen cycle |
| Evidence in TS context | Sequential progesterone is recommended in Turner syndrome guidelines to avoid abnormal uterine bleeding | Continuous progesterone is an acceptable alternative when the endometrium is stable |
| Risks | No TS‑specific risk data noted; regimen used generally in HRT protocols | No TS‑specific risk data noted; regimen used generally in HRT protocols |
| Important limitations | Study is single‑site and non‑randomized; findings may not generalize broadly | Study is single‑site and non‑randomized; findings may not generalize broadly |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days
Participants receive oral micronized progesterone either sequentially for the first 12 days of a 30 to 31-day cycle or continuously at a lower daily dose throughout the 30 to 31-day cycle.
Visits at enrollment and periodic assessments during treatment
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/35272055/Children's Mercy Hospital Kansas City
Lead Sponsor