Ignite Creation Date:
2024-05-06 @ 4:03 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02449902
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2015-05-18
Brief Title:
TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
Sponsor:
TherapeuticsMD
Organization:
TherapeuticsMD
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of TX-12-004-HR in Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy VVA
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment and to estimate the effect size and variability of vulvovaginal atrophy endpoints In addition the systemic exposure to estradiol from single and multiple doses of TX-12-004-HR was to be investigated
Detailed Description:
This study was a randomized double-blind placebo-controlled trial to evaluate safety and efficacy of the TX-12-004-HR formulation in reducing moderate to severe symptoms of vaginal atrophy associated with menopause and to investigate the systemic exposure to estradiol following once daily intravaginal administrations of TX-12-004-HR for 14 days
Postmenopausal subjects who met the study entry criteria were randomized to one of two treatment groups TX-12-004-HR or Placebo During the Screening period subjects were asked to self-assess the symptoms of vulvar andor vaginal atrophy including vaginal dryness vaginal andor vulvar irritationitching dysuria vaginal pain associated with sexual activity and vaginal bleeding associated with sexual activity Subjects with at least one self-assessed moderate to severe symptom of vulvar andor vaginal atrophy identified by the subject as being most bothersome to her were eligible to participate in the study
Postmenopausal subjects who met the study entry criteria were randomized to one of two treatment groups TX-12-004-HR or Placebo During the Screening period subjects were asked to self-assess the symptoms of vulvar andor vaginal atrophy including vaginal dryness vaginal andor vulvar irritationitching dysuria vaginal pain associated with sexual activity and vaginal bleeding associated with sexual activity Subjects with at least one self-assessed moderate to severe symptom of vulvar andor vaginal atrophy identified by the subject as being most bothersome to her were eligible to participate in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None