Clinical trials: Menopause Symptoms
Menopause, Vulvovaginal Atrophy
TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
The study was designed to evaluate the efficacy and safety of TX-12-004-HR 10 μg in treating moderate to severe symptoms of vaginal atrophy associated with menopause after 14 days of treatment, and to estimate the effect size and…
- Conditions
- Menopause, Vulvovaginal Atrophy, Painful Intercourse, Dyspareunia
- Trial name
- NCT02449902
- Testing
- Estradiol
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- TherapeuticsMD
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
Pelvic Organ Prolapse, Menopause
Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall.
- Trial name
- PET (NCT01778985)
- Testing
- Premarin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Menopause Hot Flashes
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.
- Trial name
- NCT03291067
- Testing
- MT-8554 1mg, MT-8554 5mg, MT-8554 10mg
- Where
- 63 sites in United States
- Volunteers
- 375 people
- Sponsor
- Tanabe Pharma America, Inc.
Hot Flushes
Vilazodone for Menopausal Hot Flashes
This is a pilot study to determine proof in principle that vilazodone, a selective serotonin reuptake inhibitor and 5HT1a agonist, reduces the frequency and severity of menopausal hot flashes relative to placebo.
- Trial name
- NCT01680900
- Testing
- vilazodone
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Pennsylvania
Female Urogenital Diseases, Vaginal Atrophy
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of…
- Conditions
- Female Urogenital Diseases, Vaginal Atrophy, Postmenopausal Atrophic Vaginitis, Genitourinary Disease
- Trial name
- IMPLORE (NCT03996603)
- Testing
- Conjugated Estrogens Cream
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
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
Atrophy, Vaginal Diseases
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.
- Trial name
- NCT00729469
- Testing
- Ospemifene 60 mg
- Volunteers
- 919 people
- Sponsor
- Shionogi
Contraceptive Usage, Overweight or Obesity
A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
Approximately 15 million women of reproductive age women in the United States have overweight or obesity and use the combined estrogen and progestin oral contraceptive pill (COC).
- Conditions
- Contraceptive Usage, Overweight or Obesity, Body Weight Changes, Appetitive Behavior
- Trial name
- NCT05061472
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Colorado, Denver
Postmenopausal Symptoms
A Study of the Safety and Effect of Repeated Administration of G-CSF on Hot Flashes in Postmenopausal Women
The purpose of this study is to assess the efficacy and safety of repeated administration of G-CSF for the treatment of hot flashes and vasomotor symptoms in women with naturally-occurring or surgically induced menopause.
- Trial name
- NCT03640754
- Testing
- G-CSF
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- MenoGeniX, Inc.
Metrorrhagia, Urinary Incontinence
Controlled Trial of Tele-Support and Education for Womens Health Care in CBOCs
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.
- Conditions
- Metrorrhagia, Urinary Incontinence, Remote Consultation, Videoconferencing
- Trial name
- WH CREATE P4 (NCT01918072)
- Testing
- Clinical innovation
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- VA Office of Research and Development
Combat Disorders
Prospective Study of Veteran Health in Previously Deployed Soldiers
Background: Previous deployments like that to the Persian Gulf in 1991 produced veterans with post-deployment symptom-based health problems with no medical explanation.
- Trial name
- NCT00285246
- Where
- 2 sites in United States
- Volunteers
- 838 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Genitourinary System; Disorder, Female, Burning Vagina
Laser Therapy for Treatment of Urogenital Symptoms in Women
This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.
- Conditions
- Genitourinary System; Disorder, Female, Burning Vagina, Dyspareunia, Irritation; Vagina
- Trial name
- NCT03681678
- Testing
- fCO2 Laser Therapy Group
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Corewell Health East
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
Post-menopausal Vasomotor Symptoms
Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
In this clinical research study, subjects will be given the study drug, ACER-801 (osanetant) or placebo (looks like the study drug but contains no active ingredients).
- Trial name
- NCT05325775
- Testing
- ACER-801 50 mg BID, ACER-801 100 mg BID, ACER-801 200 mg BID
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Acer Therapeutics Inc.
Vasomotor Symptoms, Menopausal Symptoms
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II)
A two-part study designed to evaluate the effect of Estetrol (E4) 15 mg, 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) in the Efficacy Study Part and the safety of E4 20 mg in the Safety Study Part.
- Trial name
- E4Comfort II (NCT04090957)
- Testing
- Estetrol oral tablet
- Where
- 117 sites in United States, Canada
- Volunteers
- 1,015 people, healthy volunteers welcome
- Sponsor
- Estetra
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
Menopause, Vasomotor Symptoms
Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)
The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity…
- Trial name
- NCT00560833
- Testing
- esmirtazapine
- Volunteers
- 943 people
- Sponsor
- Merck Sharp & Dohme LLC
Urinary Incontinence
A Comparison of Tolterodine and Placebo Treatments on Nocturnal Frequency and Sleep Quality in Women After Menopause.
This study is being done to compare frequency of urination during the night when women take tolterodine tablets vs. when they take placebo tablets.
- Trial name
- NCT00323635
- Testing
- tolterodine
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Atrophy, Vaginal Diseases
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.
- Trial name
- NCT01585558
- Testing
- Ospemifene (Dose 1), Ospemifene (Dose 2)
- Volunteers
- 180 people
- Sponsor
- Shionogi