Clinical trials: Climacteric Symptoms
Insomnia
Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.
- Trial name
- NCT03034018
- Testing
- suvorexant
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Depression
Omega-3 for Peri- and Postmenopausal Depression
The purpose of this study is to determine if an eight-week intervention with omega-3 fatty acids significantly reduces depressive symptoms in symptomatic peri- and postmenopausal women.
- Trial name
- O3Meno (NCT00825994)
- Testing
- Omega-3 Fatty Acids
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Massachusetts General Hospital
Estrogen Deficiency, Cardiovascular Disease (CVD)
Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
The purpose of this study is to determine whether young women with functional hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for pre-clinical cardiovascular disease (CVD).
- Conditions
- Estrogen Deficiency, Cardiovascular Disease (CVD), Functional Hypothalamic Amenorrhea, Endothelial Dysfunction
- Trial name
- NCT03018366
- Testing
- 17beta Estradiol, Progesterone
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Atrophy, Vaginal Diseases
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
- Trial name
- NCT01586364
- Testing
- Ospemifene 60Mg Oral Tablet
- Volunteers
- 301 people
- Sponsor
- Shionogi
Menopause, Hot Flashes
Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
The broad goal of this study is to obtain pilot data to determine the tolerability and preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime vasomotor Symptoms (VMS) when open-label…
- Conditions
- Menopause, Hot Flashes, Vasomotor Disturbance
- Trial name
- NCT02040532
- Testing
- Gabapentin
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Massachusetts General Hospital
Hot Flashes
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
This study is designed to determine the effect of a Hypnosis Intervention on reducing hot flash frequency (perceived impact vs. physiologically measured impact), severity and daily interference in post-menopausal women.
- Trial name
- NCT01293695
- Testing
- Hypnosis, Structured attention
- Where
- United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Baylor University
Menopause
Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients
The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal patients with hot flushes and night sweats.
- Trial name
- NCT00962585
- Testing
- S-equol
- Where
- 9 sites in United States, Australia
- Volunteers
- 169 people
- Sponsor
- Ausio Pharmaceuticals, LLC
Advanced ER-Positive HER2-Negative Breast Cancer
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
- Trial name
- SERENA-2 (NCT04214288)
- Testing
- AZD9833, Fulvestrant
- Where
- 85 sites in United States, Belgium and 14 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Hot Flashes
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2
This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life.
- Trial name
- Skylight 2 (NCT04003142)
- Testing
- Fezolinetant
- Where
- 93 sites in United States, Canada and 5 more
- Volunteers
- 501 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Sexual Pain Disorders, Postmenopausal Symptoms
Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment
This study will evaluate the use of topical 5 or 10% sinecatechins, a botanical drug derived from green tea for the alleviation of sexual pain in the area around the vaginal opening (the vulvar vestibule), that is a main source…
- Conditions
- Sexual Pain Disorders, Postmenopausal Symptoms, Vulvovaginal Atrophy, Female Sexual Dysfunction
- Trial name
- NCT03682601
- Testing
- 5% sinecatechins ointment, 10% sinecatechins ointment
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GTO Pharmaceutical, LLC
Postmenopausal Symptoms, Menopause
Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)
To investigate efficacy and safety of 4 doses of esmirtazapine, compared to placebo, in the treatment of moderate to severe hot flushes (vasomotor symptoms) associated with the menopause.
- Conditions
- Postmenopausal Symptoms, Menopause, Vasomotor Symptoms
- Trial name
- NCT00535288
- Testing
- Esmirtazapine
- Volunteers
- 946 people
- Sponsor
- Merck Sharp & Dohme LLC
Menopause, Postmenopausal Vaginal Atrophy
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
- Trial name
- NCT00431132
- Testing
- estradiol, 10 mcg
- Where
- 42 sites in Czechia, Denmark and 5 more
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Postmenopause
Endometrial Safety Study
The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).
- Trial name
- NCT00522873
- Testing
- 0.25mg DRSP / 0.5mg E2 (BAY86-4891), 0.5mg NETA / 1.0mg E2 (Activella)
- Where
- 59 sites in United States, Argentina and 6 more
- Volunteers
- 662 people
- Sponsor
- Bayer
Menopause, Osteoporosis
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recently gone through menopause.
- Conditions
- Menopause, Osteoporosis, Osteopenia
- Trial name
- SPARE (NCT00076050)
- Testing
- Soy isoflavones
- Where
- United States
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- University of Miami
Breast Cancer, Menopausal Symptoms
Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about differences in DNA and predict how well patients will respond to treatment and plan better treatment.
- Trial name
- NRR (NCT00764322)
- Testing
- tamoxifen citrate, gene expression analysis, pharmacogenomic studies
- Where
- 7 sites in United States
- Volunteers
- 501 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Menopausal Flushing
Neuropeptide Treatment for Hot Flushes During the Menopause
Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational product
- Trial name
- NK3R (NCT02668185)
- Testing
- NK3R antagonist - AZD4901
- Where
- United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Vasomotor Symptoms Associated With Menopause, Hot Flashes
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause
Researchers are looking for a better way to treat women who have hot flashes after they have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the…
- Trial name
- OASIS-3 (NCT05030584)
- Testing
- Elinzanetant (BAY3427080)
- Where
- 86 sites in United States, Belgium and 7 more
- Volunteers
- 628 people
- Sponsor
- Bayer
Moderate Depression, Menopausal and Postmenopausal Disorders
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
The aim of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate to severe depression in peri- and postmenopausal women.
- Trial name
- HOMDEP-MENOP (NCT01635218)
- Testing
- Individualized homeopathic treatment, Fluoxetine
- Where
- Mexico
- Volunteers
- 133 people
- Sponsor
- Hospital Juarez de Mexico
Menopause, Depression
Brain Imaging Study in Menopausal Women With and Without Major Depressive Disorder
The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in menopausal women with major depressive disorder and healthy subjects using nuclear magnetic resonance spectroscopy (MRS).
- Trial name
- NCT00626340
- Testing
- MDD diagnosis and Estrogen treatment, MDD diagnosis and Fluoxetine treatment, MDD diagnosis with both Estrogen and Fluoxetine treatment
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Menopause
Effect of Nuvigil on Fatigue
The purpose of this study is to determine if armodafinil improves quality of life and is an effective treatment of fatigue in symptomatic perimenopausal and postmenopausal women.
- Trial name
- NCT01460628
- Testing
- Armodafinil
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital