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NCT01389102 · ClinicalTrials.gov registry record · Phase 3
Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
A Phase 3 study, sponsored by Lumara Health.
- Completed
- Registry status
- Phase 3
- Development phase
- 454
- Enrollment target
NCT01389102: Completed Phase 3 study, sponsored by Lumara Health.
NCT01389102 is a Phase 3 study that has completed, run by Lumara Health. The registered enrollment target is 454 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01389102, a Phase 3 study, has completed, sponsored by Lumara Health.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 454 participants
- Enrollment target
Study Summary
Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.
Primary Outcome
Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms \[hot flushes and sweating\] experienced each day. Mild, moderate and severe hot flushes and sweating were defined as follows: Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity
Interventions
- DRUG Estradiol transdermal one 90 μL spray
- DRUG Estradiol transdermal spray, two 90 μL sprays
- DRUG Estradiol transdermal three 90 μL sprays
- DRUG Placebo transdermal two 90 μL sprays
- DRUG Placebo transdermal three 90 μL sprays
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2004-12 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
What the finished NCT01389102 record still lists
NCT01389102 is an interventional study that assigns participants to a tested intervention. The registered 454 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 5 interventions - of which Estradiol transdermal one 90 μL spray is the first listed.
NCT01389102 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01389102 about?
NCT01389102 is a clinical study titled "Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms". Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.
What is the current status of trial NCT01389102?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 454 participants. The study started on 2004-12. Estimated completion is 2006-11.
What interventions are being tested in trial NCT01389102?
The interventions under investigation include: Estradiol transdermal one 90 μL spray (DRUG), Estradiol transdermal spray, two 90 μL sprays (DRUG), Estradiol transdermal three 90 μL sprays (DRUG), Placebo transdermal two 90 μL sprays (DRUG), Placebo transdermal three 90 μL sprays (DRUG).
Who is sponsoring clinical trial NCT01389102?
This trial is sponsored by Lumara Health, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01389102's enrollment target sits among peer trials
454 831st of 2000 higher than 1,167 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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