Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05586711
Status:
RECRUITING
Last Update Posted:
2022-10-19
First Post:
2022-10-09
Brief Title:
Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women
Sponsor:
Angelica Lindén Hirschberg
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Effects of Local Dehydroepiandrosterone DHEA and Estradiol on Moderate to Severe Dyspareunia a Symptom of Vulvovaginal Atrophy in Postmenopausal Women - a Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2022-10
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:
Vulvovaginal atrophy VVA is a condition characterized by vaginal dryness itching burning irritation and dyspareunia The condition is mainly due to estrogen deficiency and is common during and after menopause Furthermore androgens may have an important function in these symptoms The purpose of the study is to compare vaginal estrogen with vaginal dehydroepiandrosterone DHEA an androgen precursor on dyspareunia primary outcome a symptom of VVA in postmenopausal women Secondary outcomes are total symptom score of VVA vaginal dryness irritationitching maturation index pH clinical signs of VVA sexual function urogenital symptoms vaginal histomorphology sex hormone levels and short-term safety The hypothesis of the study is that the treatments will have a similar effect on dyspareunia while DHEA through local androgenic effects eg growth of muscle tissue and nerve density in the vaginal wall may be more effective in treating other related symptoms such as sexual dysfunction 170 postmenopausal women will be randomly assigned to treatment with either vaginal estrogen Vagifem or vaginal DHEA Intrarosa The women are examined at the start of the study after 4 weeks of daily application and after another 8 weeks of treatment with twice a week application of the vaginal treatment The study is expected to provide increased knowledge about the effect of the treatments of VVA in postmenopausal women as well as whether vaginal DHEA has additional positive effects on sexual function compared to vaginal estrogen
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None