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| Name | Class |
|---|---|
| Biotropics Malaysia Berhad | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nu Femme | Experimental | Two capsules (500mg total) taken once daily in the morning after breakfast for 24 weeks |
|
| Placebo | Placebo Comparator | Two capsules taken once daily in the morning after breakfast for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nu Femme | Dietary Supplement | Combination product of Labisia pumila and Eurycoma longifolia extracts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of hot flashes | Assessed based on hot flash symptoms score | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of joint pain | Assessed based on joint pain symptoms score | Baseline to week 12 |
| Frequency and severity of hot flashes | Assessed based on hot flash symptoms score |
| Measure | Description | Time Frame |
|---|---|---|
| Bone markers | NTX and BSALP | Baseline to week 12 |
| Blood safety parameters | CBC, electrolytes (Na K CL), glucose, creatinine, BUN, AST, ALT, GGT, bilirubin, Ca, albumin |
Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada | ||
| Manna Research - Toronto |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo | Other |
|
| Baseline to week 24 |
| Frequency and severity of hot flashes | Assessed based on hot flash symptoms score | Week 12 to week 24 |
| Frequency and severity of joint pain | Assessed based on joint pain symptoms score | Baseline to week 24 |
| Frequency and severity of joint pain | Assessed based on joint pain symptoms score | Week 12 to week 24 |
| Health related quality of life | Assessed using the Menopause Rating Scale (MRS) | Baseline to weeks 3, 6, 12 and 24 |
| Menopause specific quality of life | Assessed using the Menopause Specific Quality of Life questionnaire (MENQOL) | Baseline to weeks 3, 6, 12 and 24 |
| Serum hormone concentrations | Estradiol-17b, FSH, LH, total testosterone and free testosterone | Baseline to week 12 |
| Serum Lipid Profile | Total cholesterol, HDL-C, LDL-C and triglycerides | Baseline to week 12 |
| Baseline to week 12 |
| Pap smear | Histological analysis for abnormal cells | Baseline to week 12 |
| Pelvic ultrasound | To determine changes in endometrial thickness | Baseline to week 12 |
| Incidence of adverse events | Baseline to week 12 |
| Toronto |
| Ontario |
| M9W 4L6 |
| Canada |
| Manna Research - Quebec | Lévis | Quebec | G6W 0M5 | Canada |
| Manna Research - Montreal | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |