A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women

Inclusion Criteria:

- Female of any race between the ages of 40 and 55 years (inclusive)

- Experiencing irregular menstrual cycles (>3 months) indicating perimenopause or
cessation of menstrual period for at least 3 months within the last 12 months. Women
must have an endometrial stripe < 4 mm by ultrasound at screening. Women with an
intact cervix must have a pap smear that is normal at screening.

- Experiences menopausal transition symptoms such as hot flushes, sweating, sleep
disturbance, migraine, anxiety, vaginal dryness and sexual problems.

- Minimum of 7 hot flashes per day or 40 per week

- Total scores of Menopause Rating Scale ≥ 28 indicating the menopausal symptoms are
moderate or severe

- 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:

- Surgical menopause

- Natural menopause ≥ 12 months amenorrhea

- Women with a positive mammogram

- Subjects without an intact uterus or ovaries

- 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 or endometriosis

- 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