Hot Flashes, PMS
Conditions
Keywords
PMS, hot flashes
Brief summary
Hot flashes are the most common symptom of menopause and affect almost 75% of menopausal women. Clinical evidence indicates potent antagonists of 5-HT2A are more likely to cause hypothermia. Risperidone is a potent 5-HT2A and a dopamine D2 receptor antagonist and is proposed to have effect on reduciton of hot flashes through its dopaminergic and serotonergic antagonism. 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.
Interventions
DRUGI placebo capsule
I placebo capsule
DRUGII RDC 0.3mg capsule
II RDC 0.3mg capsule
DRUGIII RDC 0.6mg capsule
III RDC 0.6mg capsule
Sponsors
Changhua Christian Hospital
Yung Shin Pharm. Ind. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Menopausal (postmenopausal or perimenopausal) adult women who are suffering from vasomotor symptom or women who are suffering from drug (tamoxifen or aromatase inhibitors) induced vasomotor symptoms. Women have received postsurgical bilateral oophorectomy with or without hysterectomy will be eligible for the study; \- Women who are on tamoxifen or aromatase inhibitors, it has to be for at least 8 weeks at stable dosing and will maintain at the same treatment regimen during the study; * Menopausal (postmenopausal or perimenopausal) adult women and drug (tamoxifen or aromatase inhibitors) induced vasomotor symptoms must average 3 or more moderate to severe hot flashes per day or 25 per week. Both based upon data obtained from a completed VMS episode event log for a 1 week period prior to randomization where moderate is defined as a sensation of heat with sweating, able to continue activity, and severe is defined as a sensation of heat with sweating, causing cessation of activity. Awake at night due to sweats will be recorded separately and will be considered as severe; * Ability to understand and follow the instructions of the investigator, including completion of the VMS episode event logs (patient diary) as described in the protocol; * Able and willing to provide written informed consent; * Study participants should not be taking estrogen or a SERM alone or estrogen/progestin containing drug products. The following washout periods are recommended before baseline assessments are made for subjects previously on estrogen or a SERM alone or estrogen/progestin containing products: * 1 week for prior vaginal hormonal products (rings, creams, gels); * ≥ 4 weeks for prior transdermal estrogen alone or estrogen/progestin products; * ≥ 8 weeks for prior oral estrogen, SERM and/or progestin therapy; * ≥ 8 weeks for prior intrauterine progestin therapy; * ≥ 3 months for prior progestin implants and estrogen alone injectable drug therapy; * ≥ 6 months for prior estrogen pellet therapy or progestin injectable drug therapy.
Exclusion criteria
* Hypertension with uncontrolled blood pressure (Systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 90 mmHg) Subjects with mild to moderate hypertension who are controlled on a stable antihypertension regimen may be enrolled if they meet the other inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in frequency of moderate to severe vasomotor symptoms | baseline to weeks 4 and 12 |
Countries
Taiwan
Outcome results
None listed