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Hormone Therapy

Transdermal Estrogen for Primary Ovarian Insufficiency

Phase 3

Waitlist Available

Led By Catherine Gordon, MD,Msc

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 24 months

Awards & highlights

Study Summary

This trial will compare the effects of hormone replacement therapy in women with a disorder of premature ovarian failure to a control group of healthy women.

Eligible Conditions

Primary Ovarian Insufficiency

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Anthropometrics

Bone age

Child Depression Inventory-II (CDI-II)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: POI ParticipantsExperimental Treatment1 Intervention

This group will be participants who have been recently diagnosed with POI. In an open-label fashion, participants with POI will receive Transdermal Estrogen(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).

Group II: Control ParticipantsActive Control1 Intervention

The control group will reflect a comparison group similar to the POI patient group. As bone density, body composition, and cognitive domains continue to mature throughout the teenage years, this comparison group will provide an important metric of normal growth and development.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transdermal Estrogen

2018

Completed Phase 3

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,578 Total Patients Enrolled

Patty Brisben Foundation For Women's Sexual HealthOTHER

6 Previous Clinical Trials

376 Total Patients Enrolled

Catherine Gordon, MD,MscPrincipal InvestigatorBoston Children's Hospital and Cincinnati Children's Hospital Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA okayed Transdermal Estrogen for public use?

"Transdermal Estrogen has undergone Phase 3 trials, meaning that there is both efficacy and multiple rounds of safety data. Our team at Power rates the safety a 3."

Answered by AI

What are some popular reasons why people use Transdermal Estrogen?

"Transdermal estrogen can help with amenorrhea, hypoestrogenism, menopausal hot flashes, and breast pain."

Answered by AI

How might I become involved in this research project?

"Eligible participants for this study must be between 11 and 18 years old, have primary ovarian insufficiency, and there are only 19 total spots available."

Answered by AI

Are there any available slots for patients who want to participate in this clinical trial?

"Although this particular medical trial is not looking for new patients, that was not always the case. This study was first posted on November 1st, 2018 but was most recently updated on June 13th, 2022. There are other ongoing trials that are still recruiting patients."

Answered by AI

Are elderly people being recruited for this experiment?

"In order to qualify for this study, applicants must be between 11 and 18 years old. Out of the 33 total trials, this is the 11th one for patients under 18 and the 21st one for patients over 65."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Primary Ovarian Insufficiency

Nelson, Lawrence M.. 2009. “Primary Ovarian Insufficiency”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmcp0808697.

The Journal of PediatricsJournal

The Determinants of Peak Bone Mass

Gordon, Catherine M., Babette S. Zemel, Tishya A.L. Wren, Mary B. Leonard, Laura K. Bachrach, Frank Rauch, Vicente Gilsanz, Clifford J. Rosen, and Karen K. Winer. 2017. “The Determinants of Peak Bone Mass”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2016.09.056.

Current Opinion in PediatricsJournal

Update on Primary Ovarian Insufficiency in Adolescents

Gordon, Catherine M., Tsuzuki Kanaoka, and Lawrence M. Nelson. 2015. “Update on Primary Ovarian Insufficiency in Adolescents”. Current Opinion in Pediatrics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mop.0000000000000236.

Gynecological EndocrinologyJournal