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Hormone Therapy

EstroGel® Gel 0.9 grams 0.03% for Postmenopausal Syndrome

Phase 4
Waitlist Available
Research Sponsored by ASCEND Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.

Eligible Conditions
  • Postmenopausal Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: EstroGel® Gel 1.25 grams 0.03%Experimental Treatment1 Intervention
1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks.
Group II: EstroGel® Gel 0.9 grams 0.03%Experimental Treatment1 Intervention
0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
Group III: Placebo GelPlacebo Group1 Intervention
0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estrogel
2004
Completed Phase 4
~230

Find a Location

Who is running the clinical trial?

ASCEND TherapeuticsLead Sponsor
4 Previous Clinical Trials
320 Total Patients Enrolled
Solvay PharmaceuticalsIndustry Sponsor
131 Previous Clinical Trials
37,133 Total Patients Enrolled
Global Clinical Director SolvayStudy DirectorSolvay Pharmaceuticals
79 Previous Clinical Trials
16,190 Total Patients Enrolled
~11 spots leftby Nov 2025
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