137 Clinical Trials for Various Conditions
This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States.
The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH
The objective of this study was to determine the magnitude and duration of the reduction in pH (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH was measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants were assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel (3, 4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).
To evaluate the impact of the vaginal Ph and acidification of vaginal misoprostol on its efficacy in facilitating induction of midtrimester abortion.
The goal of this clinical study is to determine if 8 treatments with photobiomodulation using near-infrared laser energy can help reduce chronic pelvic pain in women. Additionally, researchers want to determine if treatment with this type of energy can also alleviate pain with activities such as standing, sitting, urinating, having bowel movements and intercourse.
The purpose of the study is to compare, contrast, and characterize the range of user perceptions and potential acceptability of three (3) topical vaginal microbicide dosage forms.
This is a virtual single-group clinical trial lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. They will complete questionnaires and vaginal pH tests before and after product use.
This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its tolerability.
This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8).
The goal of this clinical trial is to learn about the vaginal microbiome in premenopausal women with recurrent bacterial vaginosis (BV). The main questions it aims to answer are: * Does using a specific vaginal care system reduce recurrence of BV? * How does using this vaginal care system change the vaginal microbiome and pH over time? Participants will: * Have their vaginal microbiome and pH tested in several ways at three timepoints: the start of the study, 12 weeks later, and 24 weeks after the start of the study * Answer questionnaires about vulvovaginal symptoms at each of these three timepoints * Use a specific vaginal care system at home for 24 weeks, consisting of an intimate wash, a vaginal moisturizing gel, and a vaginal probiotic suppository, if assigned to the intervention group Researchers will compare the group using the vaginal care system with a control group that does not use the system to see if using the system reduces risk of BV recurrence or changes the vaginal microbiome, pH, or symptoms.
The goal of this clinical trial is to learn about how the vaginal microbiome affects pelvic floor disorders in women who have recently given birth. The main question it aims to answer is: • Can improving the vaginal microbiome allow women to improve muscle strength, improve muscle tone, and reduce tissue inflammation faster than women who do not use a vaginal hygiene system to improve their microbiome? Over a 3-month period, participants will be assessed three times for: * vaginal microbiome * vaginal pH * pelvic muscle strength * pelvic muscle tension * vulvovaginal tissue color At each of these 3 assessments, women will answer questions on a questionnaire. Half of the women will be asked to use a vaginal hygiene system at home during these 3 months. Researchers will compare use of a three-product vaginal hygiene system plus a specific vaginal lubricant to see if using these products improves the vaginal microbiome and the pelvic floor outcomes listed above.
An over-the-counter vaginal care system is being tested to see if it may be effective in preventing recurrence of symptomatic urinary tract infection (UTI) in women who have had multiple UTIs within the past year.
In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for prevention of BV recurrence over six months of use.
This is a longitudinal, observational study with the goal of understanding vaginal microbiome changes both within a single day and across a menstrual cycle. The study will be composed of at least 10 women that have regular menstrual cycles and are 18 years of age or older. This study is direct to participant and will NOT utilize clinical sites.
The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.
The intent of this mixed methods study for transgender women after gender confirmation surgery is to characterize and subsequently create a validated screening questionnaire for postoperative urologic and pelvic floor symptoms. For individuals who seek gender-confirming treatment, about 13% undergo genital surgery for cosmetic purposes with or without gonadectomy, and this number is increasing. Patient satisfaction following surgery is high, particularly regarding sexual and cosmetic outcomes; however, unexpected negative functional outcomes such as bowel and bladder dysfunction and pelvic organ prolapse impact overall patient satisfaction. The available information suggests that 16-33% of patients experience incontinence postoperatively, with stress predominance, 32-47% experience abnormal voiding, and 24-66% experience overactive bladder symptoms. Outside of the typically assessed voiding symptoms, unique complaints of MTF postoperative patients include obstructive voiding symptoms due to urethral stenosis, persistent perimeatal erectile tissue, prostatic hypertrophy, and irritation from neovaginal tissue. Additionally, may of these patients develop symptomatic neovaginal prolapse, requiring re-suspension. We suggest that further clarification regarding MTF postoperative urologic and pelvic floor complaints can be achieved via a mixed methods approach. By using focus group interviews to create specific evaluative questions for this unique population, we can then prospectively assess patients undergoing surgery via a national multicenter sampling strategy. The goal of the study is to better understand the unique symptoms these women experience and create a validated, reliable screening questionnaire to monitor patients after surgery.
To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository or cream).
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo control in the treatment of bacterial vaginosis in non-pregnant women.
This is a multi-center, pharmacokinetic study involving a single-dose phase, a wash out phase and a two-week once or twice-daily dosing phase for each of 49 volunteers. In the single-dose phase, each volunteer will apply the single dose in the clinic. Participants will be randomized to have cervicovaginal samples and biopsies collected at one of seven time-points \[0.5, 1, 2, 4, 6, 8, and 24 hour(s)\] after the single-dose. Blood samples will be drawn at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) after the single-dose. In the two-week phase, the study supplies will be distributed and the participants will be randomized to apply each dose either once or twice-daily for two weeks. At the one week follow-up visit a blood sample will be drawn prior to the morning dose to obtain a trough value and cervicovaginal samples will be collected four hours after the morning dose. At the two week follow-up visit blood samples will be drawn prior to the morning dose to obtain a trough value and then at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) from the final morning dose. Participants will be randomized to have cervicovaginal samples and biopsies collected at either 4, 8 or 24 hours after the final morning dose. Up to 10 participants who have completed the first two phases of the study, will be asked to participate in a third phase to have cervicovaginal samples, biopsies and blood samples collected 12 hours after a single-dose.
This randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females
The goal of this clinical trial is to assess the impact of a personal care product on vaginal health in a healthy participant population. The personal care product, VM-02, contains a prebiotic, postbiotic, and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy females, together accounting for greater than 85% of known genes in this species. The intervention will be compared to a placebo intervention and will aim to assess the following in a healthy female population: Measure changes in the relative and absolute abundance of a bacterial species, Lactobacillus crispatus, in the vagina, compared the baseline (prior to use of the personal care product) to two time points after use. Observe changes in vaginal pH and self-reported discomfort from vaginal odor, compared the baseline to two time points after use. Determine the user experience of three variations of a personal care product administered in different formats to improve vaginal health and establish tolerability and user acceptability. Participants will use the personal care product according to a specific program as directed, conduct vaginal swab sampling, and answer questionnaires, each at eight time points.
This is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. We hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.
i) The primary objective of this study is to determine if physical therapy improves postoperative quality of life in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence. ii) Secondary objectives include: 1. Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care 2. Comparing sexual function in participants undergoing physical therapy compared to standard postoperative care; 3. Comparing postoperative pain scales, and activity assessment in participants undergoing physical therapy compared to standard postoperative care; 4. Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in participants undergoing physical therapy compared to standard postoperative care.
This is a proof of concept study to determine whether an extended release vaginal film can deliver drug for seven days. Two film formulations containing MK-2048 which differ by dissolution and spreadability attributes will be compared for safety and pharmacokinetic outcomes.
The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections
The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole gel in the treatment of vaginal infections
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.
This study was done to look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARVs interact with the hormones released by the birth control medication. These interactions may cause the birth control to be less effective at preventing pregnancy. There is also concern that hormonal birth control can increase HIV spreading to others, but more studies are needed to determine if this is true. The investigators did not know whether the NuvaRing and ARVs interact when they are used together, so this study looked to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV infection who are taking ARVs. The study also included HIV-infected women who were not on ARVs but used the NuvaRing to show us what the hormone levels are like in a similar group of women not on ARVs. Vaginal rings are also currently being studied to deliver anti-HIV medications that may prevent HIV acquisition, and to provide birth control over a longer period of time (more than 1 month). Since vaginal rings will become more commonly used to administer medications, the investigators wanted to better understand the potential for drug interactions with drugs given vaginally. This study will also help us understand the potential for drug interactions between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing. Additionally, this study will help us understand how hormones released from a vaginal ring affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of the female genital tract, and the immune system within the genital tract, all of which may affect the chances of spreading HIV.
This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.