A Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women

NCT02100540 | Completed Phase 2

• 1 other identifier: YSP-RCN3028-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

PMS; Hot Flashes

Keywords

PMS; hot flashes

Outcome Measures

Primary Outcomes (1)

• Mean change in frequency of moderate to severe vasomotor symptoms

  baseline to weeks 4 and 12

Study Arms (3)

I placebo capsule

PLACEBO COMPARATOR

I placebo capsule

Drug: I placebo capsule

II RDC 0.3mg capsule

EXPERIMENTAL

II RDC 0.3mg capsule

Drug: II RDC 0.3mg capsule

III RDC 0.6mg capsule

EXPERIMENTAL

III RDC 0.6mg capsule

Drug: III RDC 0.6mg capsule

Interventions

I placebo capsule DRUG

I placebo capsule

Also known as: RCN3028 placebo

I placebo capsule

II RDC 0.3mg capsule DRUG

II RDC 0.3mg capsule

Also known as: RCN3028 0.3mg capsule

II RDC 0.3mg capsule

III RDC 0.6mg capsule DRUG

III RDC 0.6mg capsule

Also known as: RCN3028 0.6mg capsule

III RDC 0.6mg capsule

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• Use of SSRI and/or SNRI. Prior usage of herbal or dietary supplements, including black cohosh, soy, phytoestrogens will be eligible if subject agrees to cease taking above agents during the study;
• Subjects taking or having taken any other experimental drugs, or participating in or having participated in other clinical studies in the 30 days prior to this clinical trial;
• Subjects having a known history of allergic reaction, hypersensitivity or clinically significant intolerance to ingredients of the study drug;
• Subject has a history or suspicion of cancer with exception of breast cancer;
• Subjects with a current drug or alcohol abuse problem as judged by the investigator;
• Subjects have clinical significant conditional, such as acute myocardial infarction or stroke with 6 months of randomization;
• Subjects have suicidal tendency;

Sponsors & Collaborators

• Yung Shin Pharm. Ind. Co., Ltd.: lead
• Changhua Christian Hospital: collaborator

Study Sites (1)

Changhua Christian Hospital

Changhua, 135, Taiwan

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 1, 2014
• Study Start: March 19, 2014
• Primary Completion: March 23, 2017
• Study Completion: September 28, 2017
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

TW (1)