Ignite Creation Date:
2024-05-05 @ 9:07 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00816556
Status:
TERMINATED
Last Update Posted:
2017-11-13
First Post:
2008-12-30
Brief Title:
A Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Sponsor:
Maire Mac Bride
Organization:
Mayo Clinic
Study Overview
Official Title:
A Randomized Controlled Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Atrophic vaginitis is a common problem that occurs in up to 40 of postmenopausal women The main symptoms are dryness itching and burning in and around the vagina These symptoms in turn can cause pain with intercourse Other symptoms can include urinary frequency and urinary urgency These symptoms are caused by the decreasing levels of estrogens in postmenopausal women
The current treatment options include hormone replacement therapy by mouth and patch and vaginal creams tablets and rings The current guideline recommend using hormone therapy at the lowest dose for the shortest time We are trying to find the lowest effective dose of estrogen cream that helps with symptoms without causing an increase in estrogens in the blood stream
We want to compare two estrogen creams estradiol and estriol each at very low doses with a placebo cream Estradiol cream is available on prescription but we want to see how effective it is at one tenth the commonly prescribed dose Estriol cream is not commonly prescribed and is only available at compounding pharmacies We want to see if either of these estrogens is effective at one tenth the usual dose We also want to see if these creams are effective when massaged onto the outer part of the vagina rather than the usual method of treatment which is inserting them into the vagina
The current treatment options include hormone replacement therapy by mouth and patch and vaginal creams tablets and rings The current guideline recommend using hormone therapy at the lowest dose for the shortest time We are trying to find the lowest effective dose of estrogen cream that helps with symptoms without causing an increase in estrogens in the blood stream
We want to compare two estrogen creams estradiol and estriol each at very low doses with a placebo cream Estradiol cream is available on prescription but we want to see how effective it is at one tenth the commonly prescribed dose Estriol cream is not commonly prescribed and is only available at compounding pharmacies We want to see if either of these estrogens is effective at one tenth the usual dose We also want to see if these creams are effective when massaged onto the outer part of the vagina rather than the usual method of treatment which is inserting them into the vagina
Detailed Description:
This trial will measure the effects of very low doses of estradiol or estriol cream applied to the vaginal introitus for the treatment of atrophic vaginitis a common condition affecting up to 40 of postmenopausal women We will conduct a randomized controlled trial with three arms-estradiol estriol and placebo The intervention will last for 12 weeks The outcomes we will be most interested in are the efficacy of the treatments for symptoms of atrophic vaginitis compared to placebo and whether there is any measurable systemic absorption from the locally applied estrogen creams These outcomes will be measured primarily by the use of patient questionnaires and secondarily clinical examination scores Safety will be evaluated with serum estrogen concentrations All measures will be collected at baseline and at the termination of the study Hormone concentrations will be collected additionally at week 2 This trial will answer important questions regarding the impact of very low doses of locally applied estrogens and symptoms of atrophic vaginitis It will provide information on effect size and validity of outcome measures It will also give information about whether low doses of estrogen creams locally applied to the vaginal introitus result in systemic absorption
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1TR000135 | NIH | None | httpsreporternihgovquickSearchUL1TR000135 |