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NCT03568708 · ClinicalTrials.gov registry record · Phase 3
Primary Ovarian Insufficiency: Phenotype and Optimal Treatment
A Phase 3 study of Primary Ovarian Insufficiency, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03568708: Completed Phase 3 study of Primary Ovarian Insufficiency, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03568708 is a Phase 3 study of Primary Ovarian Insufficiency that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 19 participants, below the 179-participant average among 3 other Primary Ovarian Insufficiency trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03568708, a Phase 3 study of Primary Ovarian Insufficiency, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot study will observe the progression of newly diagnosed POI patients physical and psychology outcomes after initiating standard of care HRT treatment in comparison to healthy female control participants' physical and psychology health over 24 months.
Primary Outcome
Change in height adjusted areal BMD Z-score of the lumbar spine from baseline to 24 months within groups. BMI Z-score, calcium intake, vitamin D intake and physical activity were included in the analysis. As DXA BMD Z-scores already include race, age, and sex, these variables were not included in the analysis. Z-scores ranging between -2.0 and 2.0 are considered normal. A Z-score \<-2.0 is considered low. This analysis considers change in Z-score, therefore a high value reflects a greater incre
Conditions Studied
Interventions
- DRUG Transdermal Estrogen
Study Locations (1)
Ohio
- Cincinnati Children's Hospital - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2023-01-05 |
| Phase | Phase 3 |
What the finished NCT03568708 record still lists
NCT03568708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 179-participant average among 3 other Primary Ovarian Insufficiency trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Primary Ovarian Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Transdermal Estrogen is the first listed.
NCT03568708 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03568708 about?
NCT03568708 is a clinical study titled "Primary Ovarian Insufficiency: Phenotype and Optimal Treatment". This pilot study will observe the progression of newly diagnosed POI patients physical and psychology outcomes after initiating standard of care HRT treatment in comparison to healthy female control participants' physical and psychology health over 24 months.
What is the current status of trial NCT03568708?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2018-11-01. Estimated completion is 2023-01-05.
What conditions does trial NCT03568708 study?
This clinical trial studies the following conditions: Primary Ovarian Insufficiency.
What interventions are being tested in trial NCT03568708?
The interventions under investigation include: Transdermal Estrogen (DRUG).
Who is sponsoring clinical trial NCT03568708?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03568708 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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