Vasomotor Symptoms Clinical Trial
Official title:
The Effect of Dose Titration and Dose Tapering on the Tolerability of DVS SR in Women With Vasomotor Symptoms Associated With Menopause: The PRIMMUS (PRIstiq for Managing Menopause and Understanding Symptoms) Study
Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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 |