A Phase 3 interventional study of Divigel in Postmenopausal Symptoms, sponsored by Upsher-Smith Laboratories. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-26.
Sponsored by Upsher-Smith Laboratories · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's enrollment of 495 is above the median of 90 across 306 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Upsher-Smith Laboratories is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily frequency and severity of moderate to severe vasomotor symptoms
vulvar and vaginal atrophy
No study locations are listed for this record.
The record gives a start of Jul 2004 and a completion of Aug 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Estradiol
Upsher-Smith Laboratories