- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02269891
A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women (14NMHB)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5R8
- KGK Synergize Inc.
-
Toronto, Ontario, Canada, M9W 4L6
- Manna Research - Toronto
-
-
Quebec
-
Levis, Quebec, Canada, G6W 0M5
- Manna Research - Quebec
-
Pointe Claire, Quebec, Canada, H9R 4S3
- Manna Research - Montreal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- Subject smokes more than 15 cigarettes a day
- History of alcohol or drug abuse within the past year
- Subject has demonstrated non-compliance with treatment while enrolled in other experimental protocols to which the Investigator has knowledge
- Subject has a mental disability or significant mental illness, legal incapacity or limited legal capacity or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or to complete the study
- History or findings of undiagnosed abnormal vaginal bleeding within the previous two years prior to the randomization visit, including conditions that, in the Investigator's opinion are likely to be the source of unpredictable vaginal bleeding (i.e. leiomyoma or endometrial polyps)
- Subject has uterine fibroids (> 2cm) or endometriosis. This assessment will be based on the size of the uterus of each participant and will be assessed by the Qualified Investigator
- Pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Positive urine pregnancy test result
- Polycystic ovary syndrome (PCOS)
- History of abnormal Pap smear
- Significant abnormal liver function as defined as AST and/or ALT > 2 x the upper limit of normal (ULN), and/or bilirubin > 2 x the ULN
- eGFR <60
- Bleeding disorders or anaemia of any etiology defined as haemoglobin ≤ 110 g/L
- Subject has taken any of the following medications in the time periods specified prior to the screening visit and during the study
Sex hormones:
Vaginal rings and vaginal creams, ointments or gels 1 week Transdermal or topical 4 weeks DHEA within 24 weeks Natural supplements advertised to have hormonal effects within 4 weeks Oral within 4 weeks Intrauterine progestin implants within 8 weeks Progestin implants and estrogen alone injections within 12 weeks Injected progestin and estrogen or androgen implants or pellets within 24 weeks
Gonadotropin-releasing hormone (GnRH) agonists within 24 weeks
Selective Estrogen Receptor Modulators (SERMs) within 4 weeks
Glucocorticoids - Chronic high dose (≥ 7.5 mg prednisone per day or equivalent) for the past 12 weeks. Exceptions: Chronic low dose corticosteroid use (< 7.5 mg prednisone per day, or equivalent) is permitted provided the subject has been stabilized on a dose for at least 12 weeks prior to randomization and maintains the current dose and dosing regimen during the study. Acute topical, inhaled, or oral (e.g. dose packs) use is not exclusionary and will be permitted during the course of the study.
Antidepressant and/or antianxiety medications within 4 weeks unless a chronic stable dose has been maintained for greater than 12 weeks. Subject must maintain current dose and dosing regimen during the study. Use of Effexor (Venlafaxine HCl) within 4 weeks is exclusionary. Use of Dixarit (Clonidine HCl) within 2 weeks is exclusionary.
Thyroid or anti-epileptic medications within 12 weeks unless a chronic stable dose has been maintained for greater than 12 weeks prior to randomization. Subjects must maintain current dose and dosing regimen during the study
Use of Prostaglandins within 4 weeks
Other investigational study medications within 4 weeks
Current use of propranolol
Current use of an intrauterine device (IUD)
Use of natural health products, such as primrose oil, black cohosh, soy products, other than vitamin and/or mineral supplements within 4 weeks
- Known allergy or hypersensitivity to study product ingredients
- Subjects on a weight reduction program or a medically supervised diet.
- Unexplained weight loss or weight gain of more than 5 kg in the month prior to randomization
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nu Femme
Two capsules (500mg total) taken once daily in the morning after breakfast for 24 weeks
|
Combination product of Labisia pumila and Eurycoma longifolia extracts
|
Placebo Comparator: Placebo
Two capsules taken once daily in the morning after breakfast for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency and severity of hot flashes
Time Frame: Baseline to week 12
|
Assessed based on hot flash symptoms score
|
Baseline to week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency and severity of joint pain
Time Frame: Baseline to week 12
|
Assessed based on joint pain symptoms score
|
Baseline to week 12
|
Frequency and severity of hot flashes
Time Frame: Baseline to week 24
|
Assessed based on hot flash symptoms score
|
Baseline to week 24
|
Frequency and severity of hot flashes
Time Frame: Week 12 to week 24
|
Assessed based on hot flash symptoms score
|
Week 12 to week 24
|
Frequency and severity of joint pain
Time Frame: Baseline to week 24
|
Assessed based on joint pain symptoms score
|
Baseline to week 24
|
Frequency and severity of joint pain
Time Frame: Week 12 to week 24
|
Assessed based on joint pain symptoms score
|
Week 12 to week 24
|
Health related quality of life
Time Frame: Baseline to weeks 3, 6, 12 and 24
|
Assessed using the Menopause Rating Scale (MRS)
|
Baseline to weeks 3, 6, 12 and 24
|
Menopause specific quality of life
Time Frame: Baseline to weeks 3, 6, 12 and 24
|
Assessed using the Menopause Specific Quality of Life questionnaire (MENQOL)
|
Baseline to weeks 3, 6, 12 and 24
|
Serum hormone concentrations
Time Frame: Baseline to week 12
|
Estradiol-17b, FSH, LH, total testosterone and free testosterone
|
Baseline to week 12
|
Serum Lipid Profile
Time Frame: Baseline to week 12
|
Total cholesterol, HDL-C, LDL-C and triglycerides
|
Baseline to week 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone markers
Time Frame: Baseline to week 12
|
NTX and BSALP
|
Baseline to week 12
|
Blood safety parameters
Time Frame: Baseline to week 12
|
CBC, electrolytes (Na K CL), glucose, creatinine, BUN, AST, ALT, GGT, bilirubin, Ca, albumin
|
Baseline to week 12
|
Pap smear
Time Frame: Baseline to week 12
|
Histological analysis for abnormal cells
|
Baseline to week 12
|
Pelvic ultrasound
Time Frame: Baseline to week 12
|
To determine changes in endometrial thickness
|
Baseline to week 12
|
Incidence of adverse events
Time Frame: Baseline to week 12
|
Baseline to week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14NMHB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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