Clinical trials: Postmenopausal Atrophic Vaginitis
Atrophic Vaginitis, Vaginal Atrophy
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term…
- Conditions
- Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva
- Trial name
- VALOR (NCT05953090)
- Testing
- 7-0940
- Where
- 14 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Stratpharma AG
Atrophic Vaginitis
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo.
- Trial name
- NCT02995694
- Testing
- Estradiol, Reference
- Volunteers
- 535 people
- Sponsor
- Alvogen Pine Brook LLC
Atrophic Vaginitis, Atrophic Vulvovaginitis
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
This clinical study will evaluate the efficacy and safety of F-GYN, a sterile injectable medical device containing non-crosslinked hyaluronic acid, in adult women with moderate to severe vaginal dryness and symptoms related to…
- Conditions
- Atrophic Vaginitis, Atrophic Vulvovaginitis, Vaginal Atrophy, Dyspareunia
- Trial name
- F-GYN (NCT07701863)
- Testing
- F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel, Standard Non-Hormonal Symptomatic Care
- Where
- 3 sites in Poland
- Volunteers
- 130 people
- Sponsor
- Biovico Sp. z o.o.
Menopause, Postmenopausal Vaginal Atrophy
Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency
This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.
- Trial name
- NCT01507454
- Testing
- estradiol, 25 mcg
- Where
- Germany
- Volunteers
- 1,613 people
- Sponsor
- Novo Nordisk A/S
Menopause, Postmenopausal Vaginal Atrophy
Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women…
- Trial name
- NCT01085877
- Testing
- estradiol, 25 mcg
- Where
- Germany
- Volunteers
- 70 people
- Sponsor
- Novo Nordisk A/S
Vaginal Atrophy
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Trial name
- NCT01256684
- Testing
- DHEA
- Where
- 33 sites in United States, Canada
- Volunteers
- 255 people
- Sponsor
- EndoCeutics Inc.
Vaginal Atrophy
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
- Trial name
- NCT01256671
- Testing
- DHEA
- Where
- 41 sites in United States, Canada
- Volunteers
- 530 people
- Sponsor
- EndoCeutics Inc.
Atrophic Vaginitis
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo.
- Trial name
- NCT02195986
- Testing
- Estradiol Vaginal Cream, 0.01%, Estrace® 0.01% cream
- Where
- 21 sites in United States
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Atrophic Vaginitis, Atrophy
Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis
This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.
- Conditions
- Atrophic Vaginitis, Atrophy, Vaginitis
- Trial name
- NCT00137371
- Testing
- PVC (daily for 21 days, 7 days off), PVC (twice weekly)
- Where
- 49 sites in United States, Canada
- Volunteers
- 480 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Atrophic Vaginitis, Vaginal Disease
Evaluation of Gynecological Acceptability of 3 Health Care Products
The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days.
- Trial name
- NCT04327947
- Testing
- Hyaluronic acid - Research product 1, Hyaluronic acid - Research product 2, Hyaluronic acid - Comparator product
- Where
- Brazil
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Herbarium Laboratorio Botanico Ltda
Menopause, Postmenopausal Vaginal Atrophy
Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.
- Trial name
- NCT01486979
- Testing
- estradiol, 10 mcg, estradiol, 25 mcg
- Where
- Germany
- Volunteers
- 58 people
- Sponsor
- Novo Nordisk A/S
Atrophic Vaginitis
Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
The purpose of this study is to characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in postmenopausal women with atrophic vaginitis.
- Trial name
- NCT00167921
- Testing
- Premarin® Vaginal Cream, Premarin® oral tablets
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Vaginal Atrophy, Atrophic Vaginitis
ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy
Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety and efficacy of the product as an adjunct treatment.
- Conditions
- Vaginal Atrophy, Atrophic Vaginitis, Genitourinary Syndrome of Menopause (GSM)
- Trial name
- ASSIST-VLA (NCT07346287)
- Testing
- 7-940
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Stratpharma AG
Atrophic Vaginitis
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
The purpose of this study is to assess the long term safety and efficacy of the vaginal application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on atrophic vaginitis in postmenopausal breast cancer…
- Trial name
- Gynoflor (NCT01370551)
- Testing
- Estriol 0.03 mg, lyophylized lactobacillus
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 16 people
- Sponsor
- Medinova AG
Menopause, Postmenopausal Vaginal Atrophy
Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
- Trial name
- NCT00108849
- Testing
- estradiol, 10 mcg
- Where
- 57 sites in United States, Canada
- Volunteers
- 309 people
- Sponsor
- Novo Nordisk A/S
Menopausal and Perimenopausal Disorder, Unspecified, Atrophic Vaginitis
Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness
This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is designed to release glycerol.
- Trial name
- NCT02029053
- Testing
- Vaginal Lubrication Ring for Vaginal Dryness
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- J3 Bioscience, Inc.
Atrophic Vaginitis, Vaginal Diseases
Evaluation of Gynecological Acceptability of a Health Care Product
The research will be conducted with a product for use in the intimate region in up to 75 research participants who will use the investigational product for 28 ± 2 days.
- Trial name
- NCT04247022
- Testing
- Health care product (intimate gel)
- Where
- Brazil
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Herbarium Laboratorio Botanico Ltda
Vaginitis, Atrophic Vaginitis
a Flexible Wound Dressing for the Management of Genital Skin Conditions
The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
- Conditions
- Vaginitis, Atrophic Vaginitis, Lichen Planus, Lichen Sclerosus
- Trial name
- NCT05396261
- Testing
- Film forming silicone gel (7-0940)
- Where
- Australia
- Volunteers
- 54 people
- Sponsor
- Stratpharma AG
Menopause, Postmenopausal Vaginal Atrophy
Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial
This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.
- Trial name
- NCT00464971
- Testing
- estradiol, 25 mcg
- Volunteers
- 102 people
- Sponsor
- Novo Nordisk A/S
Atrophic Vaginitis
An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
- Trial name
- NCT05432154
- Testing
- Film forming silicone gel (7-0940)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Stratpharma AG