a Flexible Wound Dressing for the Management of Genital Skin Conditions
VaginitisAtrophic Vaginitis3 moreThe objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients
An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
Atrophic VaginitisThe objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
Phase I-B Study to Evaluate the Safety, Tolerability and Efficacy of IZN-6NVS for the Treatment...
Atrophic VaginitisIn this open label study, 50 eligible women will be assigned to receive the investigational product (IZN-6NVS) - 2.5 g of cream/day for 14 days, followed by 3 applications per week for the next 4 weeks. Clinical assessment of the severity of vaginitis will be performed at baseline and after 2 and 6 weeks of treatment. The study will evaluate safety, tolerability and efficacy of IZN-6NVS vaginal cream, in the treatment of atrophic vaginitis (AV) and desquamative inflammatory vaginitis (DIV).
Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic...
MenopausePostmenopausal Vaginal AtrophyThis 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.
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
MenopausePostmenopausal Vaginal AtrophyThis trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic...
Atrophic VaginitisThe 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. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.
Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis
Atrophic VaginitisTo evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen...
Female Urogenital DiseasesVaginal Atrophy3 moreIn this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of vaginal estrogen use. The investigators plan to characterize the composition and dynamics of the microbiomes of the vagina, bladder, and rectum for quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) before and after eight weeks of local vaginal estrogen therapy. Although the vagina, bladder, and gut microbiomes have been increasingly independently studied, less is known about the interactions of the bacterial communities among the three environments as well as the dynamic relationship with menopausal status and vaginal estrogen therapy and the investigators seek to elucidate these relationships further.
Vaginal and Urinary Microbiome Trial
Atrophic VaginitisMenopause1 moreA randomized controlled trial looking at the effects of vaginal estrogen and a nonhormonal alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of menopause.
Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness
Menopausal and Perimenopausal DisorderUnspecified1 moreThis 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. The study will assess the duration of lubrication/ moisturization of the vagina with the VR101 intravaginal ring in place (up to 7 days) and participant satisfaction of the device. Study participants will insert the intravaginal ring and leave it in place for an initial 7 days and then repeat this process a 2nd time. Participants will respond to questionnaires, complete a daily diary and come in for 4 separate study visits. Each study visit will involve a brief vaginal exam. Upon removal of the initially inserted device (7 days after first study visit), participants will insert a second device for an additional 7 days and undergo the same evaluation.