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Menopause clinical trials

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NCT ID: NCT01975649 Completed - Menopause Clinical Trials

Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder

Start date: June 2013
Phase: Phase 4
Study type: Interventional

Hypoactive Sexual Desire Disorder ( HSDD ) is very common in postmenopausal women due to a reduction in circulating androgen levels. The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD.

NCT ID: NCT01948583 Completed - Menopause Clinical Trials

Humectant Activity of a New Formulation of Gynomunal® Vaginalgel

GYNOMUNAL®
Start date: May 2013
Phase: Phase 4
Study type: Interventional

Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness

NCT ID: NCT01942668 Completed - Menopause Clinical Trials

A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms

REPLENISH
Start date: August 5, 2013
Phase: Phase 3
Study type: Interventional

This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.

NCT ID: NCT01936441 Completed - Sleep Clinical Trials

MsFLASH-04: Pilot Trial: Telephone Behavioral Therapy for Menopause-related Sleep Disturbance

MsFLASH-04
Start date: November 2013
Phase: N/A
Study type: Interventional

Self-reported sleep complaints are common in peri- and postmenopausal women and have been identified as a key symptom of the menopausal transition. The MsFLASH study, A Pilot Trial of Telephone-Based Cognitive-Behavioral Therapy for Midlife Women with Menopause-related Sleep Disturbance, is a randomized, single-blind, placebo-controlled, two arm clinical trial. The target population will include women in general good health, aged 40-65 years, who report symptoms of insomnia (trouble sleeping) and who are bothered by hot flashes. We plan to enroll 100 women from Seattle, Washington and surrounding areas into the trial. Half of the women will be randomly assigned to receive the behavioral intervention and half to receive the behavioral control. The intervention arm participants will receive 6 sessions of a telephone-based, cognitive-behavioral therapy intervention for insomnia (CBT-I), based on state-of-the-art methods and specifically targeted to women with menopause-related sleep disturbance (CBT-I). The control arm participants will receive telephone-based Menopause Education Control (MEC) that includes elements of sleep hygiene. Assessments for both groups will be collected at baseline (pre-randomization), 8-week post-randomization, and 6-month post-randomization. The inclusion/exclusion criteria are designed to target broadly those midlife women who have menopause-related sleep disturbance and also report being bothered by vasomotor symptoms. This target population defines the clinical population seeking treatment for relief of menopause-related sleep problems. Exclusion criteria are kept minimal and intended only to exclude women with significant medical problems likely to account for their sleep problems (instead of menopause), or likely to interfere with their ability to participate in the intervention. We include women taking hormone therapy or other medication who meet these criteria because they are part of the population seeking clinical care for relief of sleep disturbances. Our primary objective is to develop an intervention that is generalizable to the greatest number of women and maximally translatable into real-world primary care practice.

NCT ID: NCT01933295 Completed - Menopause Clinical Trials

Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

Start date: March 1, 2014
Phase: N/A
Study type: Interventional

Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.

NCT ID: NCT01931436 Completed - Menopause Clinical Trials

Pharmacokinetics Study of Qing'E Pill

Start date: August 2013
Phase: Phase 1
Study type: Interventional

This study will investigate the pharmacokinetics of single and multiple doses of Qing'E pills in Chinese menopause volunteers. The main components of Qing'E pill into the blood such as psoralen and Isopsoralen will be detected.

NCT ID: NCT01918072 Completed - Clinical trials for Urinary Incontinence

Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs

WH CREATE P4
Start date: March 1, 2013
Phase:
Study type: Observational

VA community-based outpatient clinics (CBOCs) typically serve only a small number of women Veterans, and generally do not have the women's health care resources that are available in larger settings. Women Veterans using these sites for primary care must sometimes travel to other sites to receive women's health care. That can create travel burdens, reduce continuity of care, and negatively affect patient outcomes. To address this, VA is implementing a clinical operations innovation that supports women's primary care providers with a technology-based intervention that combines interactive communication with women's health specialists and ongoing education. This research study is evaluating the implementation and effects of this women's healthcare delivery innovation. Findings from this research will inform VA women's health clinical practice and education, and will advance science in delivering technology-supported non-face-to-face care that is applicable to other clinical conditions and patient populations.

NCT ID: NCT01908270 Completed - Breast Cancer Clinical Trials

Effects of Yoga on Menopausal Symptoms in Women With Breast Cancer

Start date: August 2013
Phase: N/A
Study type: Interventional

Women with breast cancer and breast cancer survivors are often bothered by menopausal symptoms to a special degree. Treatment options for those symptoms are currently limited as hormone replacement therapy is often prohibited. Yoga has been shown to reduce menopausal symptoms as well as symptoms associated with breast cancer. Therefore, this study aims to investigate whether a 12-week yoga intervention can reduce menopausal symptoms in women with breast cancer and breast cancer survivors.

NCT ID: NCT01899612 Completed - Menopause Clinical Trials

Vaginal Inflammation Markers in Postmenopausal Women With and Without Symptoms of Vaginal Inflammation

Start date: August 2010
Phase: N/A
Study type: Observational

Many postmenopausal women suffer from vaginal symptoms such as dryness, itching, and painful intercourse. The underlying pathology is unknown. Since symptoms are comparable to those found in infectious vaginitis during the reproductive life stage, the investigators hypothesize that the vaginal milieu in symptomatic postmenopausal women is comparable to inflammation in vaginitis. The investigators therefore study vaginal cytokines in symptomatic and asymptomatic postmenopausal women.

NCT ID: NCT01862861 Completed - Menopause Clinical Trials

Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study

REVERT
Start date: November 2012
Phase: N/A
Study type: Observational

Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced peri or post-menopausal women.