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Estrogen

Estradiol Hemihydrate Transdermal System for Anorexia Nervosa (PRE-GAiN Trial)

Phase 1
Waitlist Available
Led By Munier Nour
Research Sponsored by University of Saskatchewan
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 month 24
Awards & highlights

PRE-GAiN Trial Summary

This trial will study the effects of a transdermal estrogen patch on bone health in 24 adolescent females with anorexia nervosa.

Eligible Conditions
  • Anorexia Nervosa

PRE-GAiN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cortical Wall Thickness
Secondary outcome measures
Areal Bone Content
Bone Micro-architectural Parameters
Bone Strength Estimates
+2 more

PRE-GAiN Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Participants randomized to the treatment arm will be divided by maturational status: Participants who have had their first period or have a bone age greater than or equal to 14 years will receive PrClimara® 25 (estradiol hemihydrate transdermal system - 25 mcg/day) as a weekly patch, for 24 months. o These participants will also receive progesterone (Provera 10 mg tablet) orally every 4 weeks, for 7 days during the second half of the planned menstrual cycle, in order to induce a menstrual period. Participants who have not yet had their first period and have a bone age below 14 years will receive an increasing dose of estrogen. These participants will be initiated on graduated dose of transdermal 17-β estradiol patches: 3.1 mcg/day (1/8 patch) for first six-months, 6.2 mcg/day (1/4 patch) for second six-months, 12.5 mcg/day (1/2 patch) for third six-months, and 25 mcg/day (full patch) for final six-months.
Group II: No TreatmentActive Control1 Intervention
The participants in this group will not receive the estrogen patch nor the oral progesterone.

Find a Location

Who is running the clinical trial?

Jim Pattison Children's Hospital FoundationUNKNOWN
University of SaskatchewanLead Sponsor
251 Previous Clinical Trials
154,410 Total Patients Enrolled
Munier NourPrincipal InvestigatorFaculty

Frequently Asked Questions

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

What is the current tally of participants involved in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively seeking enrollees and began on January 21st 2020 with the latest update being posted May 13th 2021. 24 participants are needed at a single site for participation in the study."

Answered by AI

What criteria must be met in order to be eligible for participation in this research project?

"This experiment is recruiting 24 adolescents with anorexia nervosa aged 12 to 19. Essential requirements for applicants include: DSM-5 criteria for Anorexia Nervosa; agreement to use dependable contraceptive methods during the trial period; female sex; amenorrhea for a minimum of three months, signifying that those in whom menstruation persists are not eligible due to lack of estrogen deficiency. Additionally, each applicant must have been previously assessed by a specialist from an anorexia clinic prior to enrollment so as to rule out and treat any other potential causes of amenorrhea."

Answered by AI

What health conditions is Estradiol Hemihydrate Transdermal System usually utilized for?

"Estradiol Hemihydrate Transdermal System is commonly used for restoring menstrual cycles in those who have gone 6 months without one, as well as alleviating hypoestrogenism and the vasomotor symptoms related to menopause. It may also be prescribed as a treatment option for breast cancer."

Answered by AI

Does this clinical trial accept participants of advanced age?

"This clinical trial welcomes youths aged 12-19 to participate."

Answered by AI

Are there currently any openings in this research protocol?

"Affirmative. Clinicaltrials.gov documents that the recruitment for this trial is ongoing, having first been posted on January 21st 2020 and last amended on May 13th 2021. The hunt for 24 participants is taking place at one clinical site."

Answered by AI

Has the FDA sanctioned Estradiol Hemihydrate Transdermal System?

"The safety of Estradiol Hemihydrate Transdermal System is assessed as a 1 due to the Phase 1 nature of this trial, which suggests there are still limited data about its efficacy and safety."

Answered by AI

Who else is applying?

How old are they?
< 18
18 - 65
What site did they apply to?
Royal University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
PRE-GAiN Bone Health Pilot Study
Munier Nour 2020. "PRE-GAiN Bone Health Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04021017.
~0 spots leftby Apr 2025
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