Atrophic Vaginitis Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis
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.
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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00984399 -
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
|
N/A | |
| Completed |
NCT04079218 -
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
|
Phase 4 | |
| Recruiting |
NCT05953090 -
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
|
N/A | |
| Completed |
NCT00167921 -
Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
|
Phase 1 | |
| Completed |
NCT04327947 -
Evaluation of Gynecological Acceptability of 3 Health Care Products
|
N/A | |
| Recruiting |
NCT05118685 -
Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis
|
Phase 1 | |
| Completed |
NCT03294538 -
Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
|
Phase 3 | |
| Completed |
NCT05058313 -
Evaluation of the Safety and Performance of the MILTA GYNECO Vaginal Probe in Postmenopausal Women With Vaginal Atrophy
|
N/A | |
| Completed |
NCT02995694 -
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
|
Phase 3 | |
| Completed |
NCT02691936 -
Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy
|
N/A | |
| Recruiting |
NCT06305494 -
Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors
|
||
| Completed |
NCT02195986 -
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
|
Phase 3 | |
| Recruiting |
NCT03981458 -
Hyaluronate for the Treatment and Prevention of Recurrent Urinary Tract Infection in Women Suffering Atrophic Vaginitis
|
N/A | |
| Completed |
NCT05396261 -
a Flexible Wound Dressing for the Management of Genital Skin Conditions
|
N/A | |
| Completed |
NCT02869165 -
Vaginal and Urinary Microbiome Trial
|
Phase 4 | |
| Completed |
NCT02029053 -
Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness
|
Phase 0 | |
| Not yet recruiting |
NCT06176820 -
Vaginal Hyaluronic Acid, Arginine and Liposome Gel Versus Vaginal Lubricant in Postmenopausal Women With Genitourinary Syndrome of Menopause
|
Phase 2/Phase 3 | |
| Recruiting |
NCT02733731 -
The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis
|
Phase 1 | |
| Withdrawn |
NCT02460302 -
Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy
|
Phase 2 | |
| Completed |
NCT02313545 -
Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment of AV and DIV
|
Phase 1/Phase 2 |