Vasomotor Symptoms Clinical Trial
Official title:
A Phase 1 Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of GS1-144 Tablets
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of GS1-144 in healthy participants in Part 1 and to assess the safety and tolerability of multiple ascending doses of GS1-144 in healthy postmenopausal female participants in Part 2.
This study will be divided into two sequential parts: Part 1 single ascending dose (SAD), and Part 2 multiple ascending dose (MAD) with the overall design. Part 1 will enroll a total of approximately 38 healthy participants in five cohorts at 5 milligram (mg), 15 mg, 30 mg, 60 mg and 90 mg dose levels. Each cohort will have 2 participants receiving placebo. There is no restriction on the male-to female ratio. Part 2 will be conducted after confirming the safety and tolerability of the ->30mg dose in Part 1 and will enroll a total of approximately 30 healthy postmenopausal female participants and provisionally consists of three cohorts at 15 mg, 30 mg and 60 mg dose levels. Each cohort will have 2 participants receiving placebo. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04090957 -
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT01052454 -
Mindfulness-Based Stress Reduction for Hot Flashes
|
Phase 0 | |
Completed |
NCT00535288 -
Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)
|
Phase 3 | |
Recruiting |
NCT00906308 -
A Study of MF101 in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT01452373 -
Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT00560833 -
Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)
|
Phase 3 | |
Completed |
NCT05033886 -
A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
|
Phase 3 | |
Completed |
NCT05083884 -
A Survey About Hot Flashes in Women Going Through the Menopause
|
||
Completed |
NCT01178892 -
MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
|
N/A | |
Completed |
NCT00397176 -
Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women
|
Phase 1 | |
Recruiting |
NCT06122181 -
Study of HS-10384 in Participants of Chinese Postmenopausal Women
|
Phase 1 | |
Not yet recruiting |
NCT06393673 -
A Study to Find the Best Dose of HS-10384 to Treat Vasomotor Symptoms in Postmenopausal Women
|
Phase 2 | |
Withdrawn |
NCT02202707 -
Vasomotor Symptoms and Cardiovascular Control
|
N/A | |
Completed |
NCT00356447 -
Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.
|
Phase 3 | |
Completed |
NCT05312567 -
FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
|
Phase 2 | |
Terminated |
NCT01353963 -
Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients
|
Phase 4 | |
Completed |
NCT00446199 -
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
|
Phase 3 | |
Completed |
NCT05850338 -
Determination of the Effects of Autogenic Relaxation Exercise and Cold Pillow Application on Vasomotor Symptom Control and Quality of Life in Postmenopausal Women
|
N/A | |
Completed |
NCT02803268 -
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
|
Phase 1 | |
Completed |
NCT00683800 -
Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
|
Phase 3 |