The overall effectiveness of a targeted supplement of botanicals, isoflavones, vitamins and minerals on perimenopausal and postmenopausal women and the most common symptoms.
| ISRCTN | ISRCTN38087930 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38087930 |
| Secondary identifying numbers | DRV_PMF_DBPRCT_001 |
- Submission date
- 24/01/2025
- Registration date
- 04/02/2025
- Last edited
- 04/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
This is a study to test the effects of a food supplement formula called PeriMenoFriend. An estimated 13 million women are going through menopause in the UK. According to NHS data, less than 20% of women going through menopause choose to take HRT. Therefore, 80% choose not to take HRT or cannot take HRT, and turn to changes in their diet, lifestyle, exercise, cognitive behavioural therapy, food supplements, or a combination of these and other changes to enjoy a more comfortable menopause. PeriMenoFriend is a food supplement formula that includes isoflavones, botanicals, minerals and vitamins designed to support natural regulation of hormones through menopause for a more comfortable menopause.
Who can participate?
Perimenopausal (have had a period in the last 12 months and are of menopausal age) and postmenopausal (have been 12 consecutive months without a period and are of menopausal age) healthy volunteer women who are experiencing at least one symptom of menopause.
What does the study involve?
Participants will confirm they meet study requirements and confirm they do not meet any criteria that exclude them from taking food supplements. Participants will receive their 90-day supply of supplements in the post in one delivery, and begin taking their supplements as per the recommended dosage and instructions they receive as soon as they receive their supplements. Participants will be asked to complete a short questionnaire on the first day and on days 14, 30, 60 and 90.
What are the possible benefits and risks of participating?
The potential benefit is feeling better through menopause and relief from some symptoms of menopause.
There are no known risks associated with participating in this study for those who meet qualifying criteria.
Where is the study run from?
Virtually by Talk Health Partnership Ltd.
When is the study starting and how long is it expected to run for?
December 2024 to April 2025
Who is funding the study?
DR.VEGAN LTD
Who is the main contact?
The third-party organisation running the trial, TalkHealth Partnership Ltd, are the main point of contact: Catriona Williams, catriona.williams@talkhealthpartnership.com
Contact information
Public, Principal Investigator
talkhealth Partnership Ltd
1 Station Rd
Hook
Basingstoke
RG27 9HA
United Kingdom
| Phone | +44 (0)1256 962250 |
|---|---|
| catriona.williams@talkhealthpartnership.com |
Scientific
Select Statistical Services Ltd
Oxygen House
Grenadier Rd
Exeter Business Park
Exeter
EX1 3LH
United Kingdom
| Phone | +44 (0)1392 440426 |
|---|---|
| Jo@select-statistics.co.uk |
Study information
| Study design | Double-blind placebo-controlled interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Efficacy |
| Participant information sheet | 46739_PIS.pdf |
| Scientific title | For peri and postmenopausal women does the blind use of the PeriMenoFriend supplement formula compared to a placebo improve their menopause experience and menopause symptoms. |
| Study hypothesis | Women in perimenopause and postmenopause who take PeriMenoFriend for 90 days find it effective for their wellbeing and common symptoms of menopause. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | This is a randomised controlled trial in healthy volunteers of a food supplement that is already available for sale in the UK and does not require ethics approval under the UK’s law. |
| Condition | Perimenopause, postmenopause |
| Intervention | This is a double-blind placebo-controlled interventional study of perimenopausal and postmenopausal women taking a food supplement formula versus a placebo, assessing self-reported changes in wellbeing and common symptoms of menopause during the 90-day trial. In the recruitment phase, participants are invited to confirm: - their age - if they are a) perimenopausal or b) post-menopausal - symptoms of menopause they are experiencing on a 5-point scale (none, mild, moderate, severe, very severe) - age their symptoms began Format: PeriMenoFriend® and placebo formulas in capsule (Size 00) format Delivery to participants: Delivered in the post to participants' homes in 3 x pouches containing 60 capsules each (3 months supply). Dosage: 2 capsules per day, each day. Capsules are to be taken together, in the morning, daytime or evening, with food. Duration of Intervention: 90 days How taken: At home by individuals recruited onto the study. Participants take the supplements at a time of their choosing and convenience. Personalisation: None Modifications: None Adherence: Intervention adherence or fidelity was not monitored. |
| Intervention type | Supplement |
| Primary outcome measure | The overall effectiveness of PeriMenoFriend for menopause symptoms and wellbeing over the previous 5 days (if participants feel a difference in menopause symptoms; if participants feel better in themselves) will be measured using self-assessed questionnaires on Days 0, 14, 30, 60 and 90 |
| Secondary outcome measures | The following secondary outcome measures will assess self-reported changes in symptoms and variances between perimenopausal and post-menopausal women using self-assessed questionnaires on Days 0, 14, 30, 60 and 90: 1. The overall effectiveness of PeriMenoFriend for menopause symptoms and wellbeing over the previous 5 days in perimenopausal women 2. The overall effectiveness of PeriMenoFriend for menopause symptoms and wellbeing over the previous 5 days in postmenopausal women |
| Overall study start date | 10/12/2024 |
| Overall study end date | 30/04/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | 300 |
| Total final enrolment | 280 |
| Participant inclusion criteria | 1. Experiencing at least one symptom of menopause 2. Perimenopausal Women (have had a period in the last 12 months and are of menopausal age) 3. Postmenopausal Women (have been 12 consecutive months without a period and are of menopausal age) |
| Participant exclusion criteria | 1. Have had or are at risk of oestrogen-positive breast cancer 2. Pregnancy or breastfeeding 3. Taking the combined contraceptive pill (containing oestrogen and progesterone) 4. Taking any of these medications: Tamoxifen, Methotrexate, Levodopa, Carbidopa, Warfarin, Benzodiazepines eg Diazepam (Valium) and Clonazepam (Klonopin), Antidepressants. 5. Taking any medications or under medical supervision, please consult a doctor or healthcare professional before joining this study if you are chosen 6. Taking any supplements for menopause and associated symptoms |
| Recruitment start date | 10/12/2024 |
| Recruitment end date | 08/01/2025 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Industry
Unit 15-17
Mortimers Industrial Estate
Romsey Road
Ower
Romsey
SO51 6AF
England
United Kingdom
| Phone | +44 (0)23 8235 1500 |
|---|---|
| team@drvegan.com | |
| Website | https://drvegan.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | 1. Publication is planned in a peer-reviewed journal. 2. Reports will be produced for organisations supporting women through menopause. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 31/01/2025 | No | Yes |
Additional files
Editorial Notes
04/02/2025: Study's existence confirmed by TalkHealth Partnership Ltd.
