A Phase 3 interventional study of estrace cream (Perrigo) and estrace cream (Reference) in Atrophy, sponsored by Padagis LLC. Completed at 1 site in United States. Open to female participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Padagis LLC · Phase 3, Interventional, and Treatment
To compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of vulvar and vaginal atrophy.
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's enrollment of 695 is above the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →Padagis LLC is the lead sponsor of 36 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Has deep vein thrombosis, pulmonary embolism or history of these conditions.
estradiol cream
Drug: estrace cream (Perrigo)
estradiol cream
Drug: estrace cream (Reference)
Placebo cream
Drug: Placebo cream
Also known as: Perrigo product
Also known as: Reference Listed Drug product
Percentage of Subjects Identified as Responders
A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH \< 5.0 with a change from Visit 1 of at least 0.5.
Time frame: Day 8
Most Bothersome Symptom
Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3.
Time frame: Day 8
| Milestone | Test Product | Reference Product | Placebo Product |
|---|---|---|---|
| Started | 277 | 279 | 139 |
| Completed | 272 | 275 | 139 |
| Not completed | 5 | 4 | 0 |
A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH \< 5.0 with a change from Visit 1 of at least 0.5.
| percentage of responders | Test Product | Reference Product | Placebo Product |
|---|---|---|---|
| Percentage of Subjects Identified as Responders | 36.8 | 32.0 | 0.8 |
Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3.
| Participants | Test Product | Reference Product |
|---|---|---|
| Most Bothersome Symptom | 116 | 123 |
Collected over 8 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Product | 0/277 (0%) | 0/277 (0%) | 0/277 (0%) |
| Reference Product | 0/279 (0%) | 0/279 (0%) | 0/279 (0%) |
| Placebo Product | 0/139 (0%) | 0/139 (0%) | 0/139 (0%) |
| Age, Continuous(years) | Test Product | Reference Product | Placebo Product | Total |
|---|---|---|---|---|
| Mean | 60.3 ± 6.35 | 59.9 ± 6.31 | 59.2 ± 6.06 | 59.9 ± 6.28 |
| Sex: Female, Male(Participants) | Test Product | Reference Product | Placebo Product | Total |
|---|---|---|---|---|
| Female | 275 | 277 | 139 | 691 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Test Product | Reference Product | Placebo Product | Total |
|---|---|---|---|---|
| Hispanic or Latino | 55 | 59 | 29 | 143 |
| Not Hispanic or Latino | 220 | 218 | 110 | 548 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Test Product | Reference Product | Placebo Product | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 8 | 5 | 0 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 33 | 35 | 25 | 93 |
| White | 233 | 235 | 114 | 582 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
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Plan to share: No
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Padagis LLC