A Randomized Double-Blind, Placebo-Controlled, Parallel Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women

KGK Science Inc.4 sites in 1 country119 target enrollmentOctober 2014

ConditionsMenopausal Symptoms

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Menopausal Symptoms
Sponsor: KGK Science Inc.
Enrollment: 119
Locations: 4
Primary Endpoint: Frequency and severity of hot flashes
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the effectiveness of an herbal combination product called Nu Femme, on menopausal symptoms in peri-menopausal women.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

September 27, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

KGK Science Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female of any race between the ages of 40 and 55 years (inclusive)
•Experiencing perimenopause (irregular menstrual cycles (\>3 months) or cessation of menstrual period for at least 3 months within the last 12 months) OR women in menopause (cessation of menstrual period for at least 12 months).
•Peri-menopausal women must have an endometrial stripe \< 8 mm by ultrasound at screening and menopausal women must have an endometrial stripe \< 5 mm. Not required for subjects without an intact uterus.
•Women with an intact cervix must have a pap smear that is normal within 12 months of screening.
•Experiences menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
•Minimum of 4 hot flashes per day or 28 per week
•Total scores of Menopause Rating Scale ≥17 indicating the menopausal symptoms are moderate or severe
•TSH screening to exclude undiagnosed hyperthyroidism
•Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.

Exclusion Criteria

•Women with a positive mammogram
•Significant cardiac history including uncontrolled hypertension (defined as untreated systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg) or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
•Uncontrolled hyperlipidemia
•History or current diagnosis of breast cancer or breast cancer in an identical twin, or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to randomization. Subjects with other cancers in full remission more than 5 years after diagnosis are acceptable with the exceptions of breast cancer or genital organ cancer (e.g., cervical cancer, uterine cancer, endometrial cancer, or ovarian cancer)
•Uncontrolled diabetes (Type I or Type II)
•Uncontrolled and/or untreated thyroid disorder
•History or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
•History or current diagnosis of autoimmune conditions, immunodeficiency or gynaecological disease
•Clinically significant mental depression that is not well-controlled in the opinion of the investigator
•Subject has undergone major surgery within the past one year prior to the randomization visit, except cholecystectomy, and appendectomy