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Vaginal Atrophy clinical trials

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NCT ID: NCT01846442 Completed - Vaginal Atrophy Clinical Trials

Topical DHEA Against Vaginal Atrophy

Start date: June 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA in postmenopausal women suffering from vaginal atrophy.

NCT ID: NCT01432470 Completed - Postmenopause Clinical Trials

Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women

Start date: August 2010
Phase: Phase 2
Study type: Interventional

Up to 50% of all postmenopausal women, experience vaginal dryness, irritation, burning, itching or discomfort, which often make sex to become difficult or painful. These symptoms combined are known as vaginal atrophy. Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier, and less elastic due to the lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections. The mucosal epithelium shows signs of severe atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells. Estrogen treatment either as hormone replacement therapy or topical application is a common treatment for vaginal atrophy. However, some women experience adverse reactions such as uterine bleeding, perineal pain and breast pain and many women are also reluctant to use estrogens due to a general negative view to this topic in the society. Oxytocin is a peptide hormone, which is normally released into the circulation via the pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. In addition, oxytocin has in vitro been shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women. Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation, topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal atrophy. In one previous placebo-controlled study on 20 postmenopausal women suffering from vaginal atrophy, a gel containing oxytocin for topical intra-vaginal administration was applied daily for seven days. The results indicated that for subjects receiving topical oxytocin the vaginal atrophy assessed by histological examination was reversed after treatment. A similar effect was not seen in the placebo group, which indicated a difference between placebo and active treatment. However, the limited number of exposed subjects in this pilot study necessitates a larger study in order to generate conclusive proof of concept data for the effects of oxytocin on vaginal atrophy. Due to the limitations of estrogens in the treatment of vaginal atrophy, many postmenopausal women are left without an effective remedy. Hence, there is a need for alternative non-estrogenic treatments of this indication. The present study is aiming to investigate the efficacy of topical oxytocin in the treatment of vaginal atrophy. The main objective of this study is to investigate if topical oxytocin can reverse vaginal atrophy, as assessed by cytological examination of the vaginal mucosal epithelium, in postmenopausal women after 12 weeks of treatment as compared to placebo.

NCT ID: NCT01358760 Completed - Vaginal Atrophy Clinical Trials

Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

NCT ID: NCT01256684 Completed - Vaginal Atrophy Clinical Trials

DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

NCT ID: NCT01256671 Completed - Vaginal Atrophy Clinical Trials

DHEA Against Vaginal Atrophy - Safety Study of 12 Months

Start date: December 2010
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00803335 Completed - Clinical trials for Pelvic Organ Prolapse

The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse

Start date: December 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.

NCT ID: NCT00607295 Completed - Breast Cancer Clinical Trials

Efficacy and Safety of Clino-san on Vaginal Dryness of Breast Cancer Patients

Start date: December 2007
Phase: Phase 3
Study type: Interventional

1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life. 2. "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks. 3. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.

NCT ID: NCT00429806 Completed - Vaginal Atrophy Clinical Trials

DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy

Start date: November 2006
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the systemic bioavailability of DHEA and its metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA concentration.

NCT ID: NCT00238732 Completed - Vaginal Atrophy Clinical Trials

Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause

Start date: October 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.