MedTrace Logo

Primary Ovarian Insufficiency: Phenotype and Optimal Treatment

NCT03568708 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-06-25

Study results available
· View outcomes & findings →

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.

Conditions

  • Primary Ovarian Insufficiency

Interventions

DRUG

Transdermal Estrogen

In an open-label fashion, participants with POI will receive transdermal estradiol (beginning at a dose of 25 µg/patch applied weekly), with the dose increased at 3, 6 12, and 18 months (to 37.5, 50, 75, and 100 µg/patch).

Sponsors & Collaborators

  • Patty Brisben Foundation For Women's Sexual Health

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Catherine Gordon, MD,Msc · Boston Children's Hospital and Cincinnati Children's Hospital Medical Center

  • Halley Wasserman, MD, MSc · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2023-01-05
Completion
2023-01-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568708 on ClinicalTrials.gov