CLINICAL TRIALS PROFILE FOR BRISDELLE
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All Clinical Trials for BRISDELLE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00786188 ↗ | Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause | Completed | Noven Therapeutics | Phase 2 | 2008-11-01 | This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows: - Moderate VMS: Sensation of heat with sweating, able to continue activity - Severe VMS: Sensation of heat with sweating, causing cessation of activity |
| NCT01101841 ↗ | 24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms | Completed | Noven Therapeutics | Phase 3 | 2010-03-01 | To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause |
| NCT01361308 ↗ | Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS) | Completed | Noven Therapeutics | Phase 3 | 2011-05-01 | The purpose of this study is to assess the safety & efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause. |
| NCT01829919 ↗ | Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women | Completed | Noven Therapeutics | Phase 1 | 2011-07-01 | The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate) Capsules 7.5 mg when given as a single dose and multiple doses. |
| NCT06161792 ↗ | Evaluate RCN3028 in Treatment of Drug-Induced VMS in Breast Cancer | Terminated | Yung Shin Pharm. Ind. Co., Ltd. | Phase 2 | 2019-11-07 | Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have been identified in previous studies as a significant reason for not persisting with the treatment in 16 - 30 % of breast cancer patients. The primary purpose of this study is to determine if RCN3028 is effective and safe in the treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per day, or 50 per week at baseline. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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