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Menopause clinical trials

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NCT ID: NCT00064831 Completed - Menopause Clinical Trials

Black Cohosh Extract in Postmenopausal Breast Health

Start date: July 2003
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to determine if black cohosh extract (BCE) administration in symptomatic postmenopausal women results in estrogenic stimulation of the breast, as determined by estradiol, pS2, FSH, LH, and PSA levels in nipple aspirate fluid.

NCT ID: NCT00061711 Completed - Menopause Clinical Trials

Alternative Therapies for Menopause: A Randomized Trial

Start date: July 2000
Phase: N/A
Study type: Interventional

This randomized, controlled trial will evaluate the efficacy and safety of three alternative approaches utilizing phytoestrogens to treat hot flashes and night sweats in peri- and post-menopausal women. The treatments were chosen because of the scientific evidence supporting a possible benefit, the availability of products with adequate quality control, and their frequency of use in naturopathic medicine. RECRUITMENT FOR THIS STUDY SHOULD END BY AUGUST 1, 2003.

NCT ID: NCT00041431 Completed - Clinical trials for Cardiovascular Diseases

Estrogen, Cytokines and Heart Failure in Women

Start date: December 2001
Phase: N/A
Study type: Interventional

To determine the effects of estrogen therapy on postmenopausal women with congestive heart failure.

NCT ID: NCT00035659 Completed - Clinical trials for Cardiovascular Diseases

Longitudinal Study of the Menopause and Fat Patterning

Start date: April 2002
Phase:
Study type: Observational

To study the natural history of the accumulation of intra-abdominal fat as women progress through the menopause.

NCT ID: NCT00029757 Completed - Menopause Clinical Trials

Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women

Start date: n/a
Phase: N/A
Study type: Interventional

Background: The use of estrogen in postmenopausal (or surgically menopausal) women is a common practice. Compliance is problematic in that estimates show only 1/3 of women use hormone replacement therapy (HRT) and only 30% are compliant. Estrogen has many documented benefits including symptomatic relief of hot flashes, improvement of the dry vagina and dyspareunia. Estrogen has been found to improve bone mineral density and increase the high- density lipoprotein portion of a cholesterol panel. To improve compliance and to provide an alternate method of delivery, we propose the use of estrogen which is admixed in toothpaste and propose to study the absorption, rate of build-up and rate of decline. Hypothesis: Estrogen can potentially be absorbed systemically when toothpaste is admixed with estradiol and is applied in a timed, consistent fashion to postmenopausal or surgically postmenopausal women, not on HRT. Absorption takes place across the buccal mucosa. Specific Aims:1) To estimate the systemic absorption of estrogen from daily use of estrogen containing toothpaste. 2) To estimate the rate of build-up of serum estrogen levels based upon daily use of toothpaste containing estrogen for eight days. 3) To estimate the rate of decline in serum estrogen levels when the use of estrogen containing toothpaste is discontinued for a week.

NCT ID: NCT00027209 Completed - Epilepsy Clinical Trials

Hormone Replacement in Menopausal Women With Epilepsy

Start date: n/a
Phase: Phase 2
Study type: Interventional

The goal of this study is to evaluate the effect of synthetic hormone replacement therapy on anti-seizure medication levels, menopausal symptom relief, and seizure frequency and safety in menopausal women with epilepsy.

NCT ID: NCT00012909 Completed - Menopause Clinical Trials

Development and Evaluation of a Hormone Replacement Therapy Decision-Aid

Start date: n/a
Phase: N/A
Study type: Interventional

The decision regarding the use of post-menopausal estrogen hormone replacement therapy (HT) is complex because patients must balance the short and long-term risks and benefits. Information from new and important clinical trials must also be considered. The purpose of this research is to develop and evaluate the efficacy of a HT CD-ROM decision-aid in improving the decision making process for women considering the use of estrogen HT.

NCT ID: NCT00010959 Completed - Menopause Clinical Trials

Single-Dose Study of Black Cohosh and Red Clover

Start date: February 2001
Phase: Phase 1
Study type: Interventional

This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined.

NCT ID: NCT00006503 Completed - Clinical trials for Cardiovascular Diseases

Prevalence & Progression of Subclinical Atherosclerosis

Start date: August 2000
Phase: N/A
Study type: Observational

To evaluate subclinical atherosclerotic disease in menopausal women.

NCT ID: NCT00005769 Active, not recruiting - Menopause Clinical Trials

Hormone Replacement Therapy and Insulin Action: A Double-Blind, Parallel, Placebo-Controlled Hormone Intervention Study in Postmenopausal Women

Start date: n/a
Phase: Phase 2
Study type: Interventional

Considerable controversy exists regarding the effect of estrogen and progesterone on insulin sensitivity in postmenopausal women. Thus, the goal is to examine the effect of estradiol and progestin on in vivo insulin sensitivity and pathways of intracellular glucose metabolism in postmenopausal women. This will be accomplished by examining the effects of unopposed estrogen (CEE) or combination estrogen and progestin (CEE/MPA) versus placebo therapy in 30 early menopausal women (defined from 6 months to 3 years post-cessation of menses). Women will be treated for 16 weeks and the outcome measures will be: 1) insulin sensitivity and glucose oxidation as determined by euglycemic clamp, 2) assessments of insulin sensitivity on muscle biopsy cultures with the primary endpoints being glucose uptake and glycogen accumulation/synthesis, 3) protein levels of insulin action cascade steps based on muscle biopsy Western blots.