Menopausal SymptomsPhase 214NMHBNCT02269891
A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women
A Phase 2 study testing Nu Femme in people with Menopausal Symptoms, run by KGK Science Inc. at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Symptoms
- What is being tested?
- Nu Femme
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 4 sitesCanada
- Study dates
- Oct 2014to 27 Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 40Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Manna Research - Quebec
Lévis, Quebec, G6W 0M5
KGK Synergize Inc.
London, Ontario, N6A 5R8
Manna Research - Montreal
Pointe-Claire, Quebec, H9R 4S3
Manna Research - Toronto
Toronto, Ontario, M9W 4L6
About this study
Official title: 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
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.
- Conditions
- Menopausal Symptoms
- Being tested
- Nu Femme, Placebo
- Keywords
- Menopausal symptoms, Peri-menopause, Nu Femme, Labisia pumila, Eurycoma longifolia, Hot flash, Joint pain
- Medical subject headings
- Hot Flashes, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nu FemmeDietary supplement
Combination product of Labisia pumila and Eurycoma longifolia extracts
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Nu Femme | Experimental | Two capsules (500mg total) taken once daily in the morning after breakfast for 24 weeks Receives: Dietary Supplement: Nu Femme |
| Placebo | Placebo comparator | Two capsules taken once daily in the morning after breakfast for 24 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of hot flashes
Assessed based on hot flash symptoms score
Measured: Baseline to week 12
Secondary outcomes (9)
Frequency and severity of joint pain
Assessed based on joint pain symptoms score
Measured: Baseline to week 12
Frequency and severity of hot flashes
Assessed based on hot flash symptoms score
Measured: Baseline to week 24
Frequency and severity of hot flashes
Assessed based on hot flash symptoms score
Measured: Week 12 to week 24
Frequency and severity of joint pain
Assessed based on joint pain symptoms score
Measured: Baseline to week 24
Frequency and severity of joint pain
Assessed based on joint pain symptoms score
Measured: Week 12 to week 24
Health related quality of life
Assessed using the Menopause Rating Scale (MRS)
Measured: Baseline to weeks 3, 6, 12 and 24
Menopause specific quality of life
Assessed using the Menopause Specific Quality of Life questionnaire (MENQOL)
Measured: Baseline to weeks 3, 6, 12 and 24
Serum hormone concentrations
Estradiol-17b, FSH, LH, total testosterone and free testosterone
Measured: Baseline to week 12
Serum Lipid Profile
Total cholesterol, HDL-C, LDL-C and triglycerides
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion27 Sep 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotropics Malaysia Berhad
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269891
- Sponsor's protocol ID
- 14NMHB
- Acronym
- 14NMHB
- Status last verified
- Nov 2018
- First submitted
- 17 Oct 2014
- Last updated
- 13 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02269891
- Acronym / sponsor ID
- 14NMHB / 14NMHB
- Conditions
- Menopausal Symptoms
- Keywords
- Menopausal symptoms, Peri-menopause, Nu Femme, Labisia pumila, Eurycoma longifolia, Hot flash, Joint pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biotropics Malaysia Berhad
- Study start
- Oct 2014
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nu Femme | Experimental | Dietary Supplement: Nu FemmeTwo capsules (500mg total) taken once daily in the morning after breakfast for 24 weeks |
| Placebo | Placebo comparator | Other: PlaceboTwo capsules taken once daily in the morning after breakfast for 24 weeks |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (40 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nu FemmeCombination product of Labisia pumila and Eurycoma longifolia extracts | Dietary supplement | Nu Femme |
| Placebo | Other | Placebo |
Primary outcome
Frequency and severity of hot flashes
Time frame: Baseline to week 12
Assessed based on hot flash symptoms score
9 secondary outcomes
Frequency and severity of joint pain
Time frame: Baseline to week 12
Frequency and severity of hot flashes
Time frame: Baseline to week 24
Frequency and severity of hot flashes
Time frame: Week 12 to week 24
Frequency and severity of joint pain
Time frame: Baseline to week 24
Frequency and severity of joint pain
Time frame: Week 12 to week 24
Health related quality of life
Time frame: Baseline to weeks 3, 6, 12 and 24
Menopause specific quality of life
Time frame: Baseline to weeks 3, 6, 12 and 24
Serum hormone concentrations
Time frame: Baseline to week 12
Serum Lipid Profile
Time frame: Baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nu Femme in people with Menopausal Symptoms, run by KGK Science Inc. at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of hot flashes (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.