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Menopause clinical trials

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NCT ID: NCT03704454 Recruiting - Menopause Clinical Trials

The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.

NCT ID: NCT03602573 Recruiting - Menopause Clinical Trials

Liver Fibrosis in Peri-menopausal Women

Start date: August 1, 2018
Phase:
Study type: Observational

This is a prospective observational study in a single medical center. The aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (VCTE) with controlled attenuation parameter (CAP) and serum biomarkers. Recruitment period: 2018/08/01 to 2019/07/31 Patient number: 200 females Inclusion criteria: 1. Females, age of 46-55 years 2. Willing and able to comply with the study requirements 3. Willing and able to provide written informed consent to participate in the study Exclusion criteria: 1. Unable to complete the noninvasive procedure of VCET and CAP 2. Unwilling to provide written informed consent to participate in the study Laboratory tests and examinations: Baseline and two follow-up visits (every 6 months): 1. Blood pressure 2. BW, BH, waist circumference, BMI 3. Complete blood cell (CBC) count 4. Albumin, AST, ALT, alkaline phosphatase, total bilirubin, r-GT, uric acid, hsCRP 5. Sugar (fasting), HbA1c, insulin, HOMA-IR 6. DM lipid profiles, adiponectin, leptin 7. Liver ultrasound, FibroScan touch 520 8. FSH, Estrodiol (E2), LH 9. TSH, free T4 10. HBsAg, anti-HCV, HBV DNA, HCV RNA, HBsAg quantification, HBV genotype (if HBsAg or anti-HCV positive) 11. ANA, Anti-mitochondrial antibody 12. Review history of drug and menstruation cycles

NCT ID: NCT03556800 Recruiting - Menopause Clinical Trials

Study to Investigate the Pharmacokinetics & Safety Following One Application of 3 Different Doses 0.5,0.75,& 1.25 gm,a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGel 1.25 gm to Healthy Post-menopausal Women.

Start date: May 22, 2018
Phase: Phase 1
Study type: Interventional

This study is a Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety following a Single Application of Three Different Doses 0.5 gm (0.5 mg estradiol), 0.75 gm (0.75 mg estradiol) and 1.25 gm (1.25 mg estradiol), a Transdermal Estradiol Cream (VML-0203), in comparison to a single dose of EstroGelTM 1.25 gm (1 unit/0.75 mg of estradiol) to healthy post-menopausal women.

NCT ID: NCT03505905 Recruiting - Clinical trials for Major Depressive Disorder

A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

Start date: September 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

HYPOTHESIS: Pregnenolone administration will be associated with greater reduction in depressive symptom severity than placebo in women with current mMDD. STUDY AIMS: Primary Aim: Determine if pregnenolone is associated with greater reduction in depressive symptom severity than placebo in women with mMDD, as measured by MADRS. Secondary Aims: 1. Determine if pregnenolone is associated with greater reduction in anxiety symptom severity than placebo in women with mMDD. 2. Determine if pregnenolone is associated with greater improvement in cognition than placebo in women with mMDD. 3. Determine if pregnenolone is associated with greater improvement in quality of life than placebo in women with mMDD. 4. Determine if pregnenolone is associated with greater improvement in vasomotor symptoms of menopause than placebo. Mechanistic Aims: 1. Determine whether changes in neurosteroid levels with pregnenolone mediate clinical response. 2. Determine if baseline neurosteroid levels predict pregnenolone response. 3. Determine whether depressive symptoms, anxiety, sleep or vasomotor symptoms improve first. A crossed-lagged panel model will explore serial correlations between changes in outcome measures.

NCT ID: NCT03116022 Recruiting - Menopause Clinical Trials

Use of Estriol at Distal Third of Vagina Improving Coital Pain in Post-menopause Women

Start date: June 1, 2017
Phase: Phase 1
Study type: Interventional

Hypoestrogenism leads to vaginal wall changes resulting in diminished vaginal lubrication and, consequently, causing pain during intercourse. Topical estrogen therapy (THT) may control this complaint. However, there are limitations on its use, especially in patients with breast cancer and diagnosed endometrial cancer. This randomized clinical trial aims to assess the impact of local estriol therapy in postmenopausal women complaining of coital pain and to assess serum concentrations of estriol in these women after estriol use. One-hundred-thirty-two women aged between 40 and 65 years will be randomized into three groups: Women using estriol 1 mg / 1g at the proximal third of vagina every other night - estriol proximal group (PEG), women in using estriol 1 mg / 1g at the distal third of the vagina every other night - estriol distal group (DEG), gel group (GG) using water-based during intercourse.

NCT ID: NCT03032185 Recruiting - Menopause Clinical Trials

Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Postmenopausal Women

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Introduction: Menopause is the last menstrual period, it is a natural phenomenon to all women. Postmenopausal, some women may experience unpleasant symptoms such as hot flushes, urogenital pain, headache and pains in the musculoskeletal system. That happens due to the decreased ovarian hormone secretion and changes in the autonomic system. Pain is also caused by a complex autonomic activity. For pain management, a therapeutic electrical stimulation of the peripheral nervous system promotes modulation of nociceptive incentives and release of endogenous opioids. According to reviewed studies, the use of transcutaneous electrical nerve stimulation (TENS), by directly stimulating the central nervous system, has presented results of manipulation of the autonomic system, being observed change in heart rate and cognitive improvement in dementia. Given this possibility, the present study aims to investigate whether the use of Transcutaneous Electrical Nerve Stimulation in low frequency can generate autonomic and psychophysical changes in healthy postmenopausal women. Objective: To evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation on autonomic and psychophysical parameters in postmenopausal women. Methods: randomized, crossover, double-blind. A sample of thirty patients will be selected according to inclusion and exclusion criteria previously established. The autonomic and psychophysical functions will be evaluated by Quantitative Sensory Testing and Conditioned Pain Modulation (pain thresholds to heat and modulation of conditioned pain, respectively), as well as scales to evaluate catastrophism and sleep quality (by scale of Pittsburgh Sleep Quality Index). After application of the scales, the participants will be subject to active Ttranscutaneous Electrical Nerve Stimulation session or sham with a fortnight washout as randomization. All the research subjects will be invited to participate in the study and sign an Informed Consent and Informed (ICI). This study will be registered in the Clinical Trials.

NCT ID: NCT02968342 Recruiting - Menopause Clinical Trials

Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women

Start date: July 2016
Phase: Phase 4
Study type: Interventional

The objective of this study is the role of vaginal progesterone gel in the treatment of menopausal hypoactive sexual desire disorder. Half of the study participants will receive a standard dose of self applied vaginal progesterone gel and the other half will receive oral vitamin tablets.

NCT ID: NCT02445716 Recruiting - Menopause Clinical Trials

Transdermal Testosterone Nanoemulsion in Women Libido

Biolipid/B2
Start date: October 2015
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, placebo-controlled study. Seventy women, aged 35-75 years, with treatment-emergent loss of libido will be randomly allocated to the treatment with a Transdermal nanoemulsion of Testosterone (500mcg) delivering 300 mcg of testosterone/day or an identical placebo nanoemulsion (PLA) for 12 weeks.

NCT ID: NCT02093650 Recruiting - Quality of Life Clinical Trials

Black Cohosh Extract for Treatment of Moderate to Severe Menopausal Symptoms

BCOMS
Start date: March 2014
Phase: Phase 3
Study type: Interventional

Compare the treatment efficacy of black cohosh extract 80 mg daily and placebo for moderate to severe menopausal symptoms

NCT ID: NCT02006238 Recruiting - Menopause Clinical Trials

A Comparison of Farabloc Fabric With Placebo on Alleviation Hot Flash in Menopausal Women

Flash
Start date: February 2014
Phase: N/A
Study type: Interventional

This is a prospective, randomized, double-blind, crossover study. The purpose of this study is to determine whether Farabloc fabric is effective in alleviation of hot flash symptoms in menopausal women. This study will require all prospective participants to fill out a week of Hot Flash Diary to determine eligibility before beginning the study. All prospective participants will be assessed for hot flash frequency, hot flash distress and hot flash severity according to their perception in the Hot Flash Diary during the experimental period.