PMSNCT05518006
An Investigation of Premama Balance and Its Effects on Hormonal Imbalances
A study testing PreMama Balance in people with PMS and Menstrual Discomfort, run by Premama Inc..
Trial summary
An investigation of the dietary supplement marketed as "Premama Balance" on markers of subjective wellbeing in trial participants such as common symptoms of PMS and menstrual symptoms, as well as its effects on aiding in returning to their perceived regular/normal menstrual cycle. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PMS, Menstrual Discomfort, Hormone Disturbance
- What is being tested?
- PreMama Balance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2022to 30 Jun 2023
- Phase
- Interventional
- 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 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- Must be on hormonal birth control (containing both progesterone and estrogen) for the past 6 months \& willing to stop using it to participate in the study
- Must be willing to get off of hormonal birth control for the study period
- Must be able to track their menstrual cycle
- BMI under 40
- Agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study
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- Willingness to adhere to the dietary supplement regimen
- Willingness to refrain from any other dietary supplements targeting the menstrual cycle and hormone control during the study period
- Is able to communicate in English
- Is willing and able to share feedback via the used technology portal
- Must provide written informed consent (ICF)
Who cannot join
- History of oncological (including ovarian cancer) or psychiatric conditions
- History of uncontrolled health conditions
- History of hysterectomy or ovariectomy
- History of diabetes \& thyroid disorders
- Smoker
- More than 3 servings of alcohol a day
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- Undergoing hormonal therapy of any kind
- Menopausal or peri-menopausal
- Not starting any other form of contraceptive other than condoms, abstinence, planned sexual intercourse
- Usage of any medication or herbal remedies/supplements which can affect the menstrual cycle or hormonal balance
- If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study
About this study
Official title: An Exploratory Investigation of Dietary Supplementation and the Effect on the Regularity of Menstrual Cycles, Hormone Balance, and Common PMS Symptoms in Females
An investigation of the dietary supplement marketed as "Premama Balance" on markers of subjective wellbeing in trial participants such as common symptoms of PMS and menstrual symptoms, as well as its effects on aiding in returning to their perceived regular/normal menstrual cycle.
- Being tested
- PreMama Balance, Placebo Drink
- Keywords
- PMS, Menstrual Discomfort, Hormone Disturbance, Menstrual Pain, Menstrual Irregularity
- Medical subject headings
- Endocrine System Diseases, Dysmenorrhea, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreMama BalanceDietary supplement
Premama Balance is a blend of the following: Vitex (Chasteberry Extract), commonly used to help regulate hormones; Antioxidants, Selenium, and Magnesium, also help support the cleansing of hormonal birth control from the liver and help strengthen the uterine lining.
Placebo DrinkDietary supplement
Blended Placebo drink
| Study group | Role | What they receive |
|---|---|---|
| PreMama Balance | Experimental | Each day, the participants will take 1 packet of Premama Balance, dissolved in one glass (8oz+) of water. Premama Balance may be taken with or without food. Should participants present themselves with a sensitive stomach, it is recommended to take the drink with or after a meal to avoid an upset stomach. Participants will repeat this process daily for 6 months/24 weeks (study period) until the study is complete.
At week 12 and in week 24, the participants will take a survey and a hormone test to track progress. In total there will be 3 surveys and 3 hormone tests. Additionally, participants will fill out a weekly consumption survey to track compliance. Receives: Dietary Supplement: PreMama Balance |
| Placebo Drink | Placebo comparator | Each day, the participants will take 1 packet of Placebo Drink, dissolved in one glass (8oz+) of water. Placebo Drink may be taken with or without food. Should participants present themselves with a sensitive stomach, it is recommended to take the drink with or after a meal to avoid an upset stomach. Participants will repeat this process daily for 6 months/24 weeks (study period) until the study is complete.
At week 12 and in week 24, the participants will take a survey and a hormone test to track progress. In total there will be 3 surveys and 3 hormone tests. Additionally, participants will fill out a weekly consumption survey to track compliance. Receives: Dietary Supplement: Placebo Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to perceived regular/normal menstrual cycle
Survey Based Assessment of changes in menstrual cycle
Measured: 6 Months
Changes in PMS and Menstrual Symptoms: Cramps, Bloating, Mood swings
Survey-based assessment of changes in PMS and Menstrual symptoms
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start30 Dec 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: Sponsor funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PMSStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Premama Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Susanne Mitschke, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518006
- Sponsor's protocol ID
- 20223
- Status last verified
- Apr 2024
- First submitted
- 24 Aug 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of Dietary Supplementation and the Effect on the Regularity of Menstrual Cycles, Hormone Balance, and Common PMS Symptoms in Females
- ClinicalTrials.gov ID
- NCT05518006
- Acronym / sponsor ID
- 20223
- Keywords
- PMS, Menstrual Discomfort, Hormone Disturbance, Menstrual Pain, Menstrual Irregularity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Premama Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Aug 2022 (actual)
- 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.
An investigation of the dietary supplement marketed as "Premama Balance" on markers of subjective wellbeing in trial participants such as common symptoms of PMS and menstrual symptoms, as well as its effects on aiding in returning to their perceived regular/normal menstrual cycle.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PreMama Balance | Experimental | Dietary Supplement: PreMama BalanceEach day, the participants will take 1 packet of Premama Balance, dissolved in one glass (8oz+) of water. Premama Balance may be taken with or without food. Should participants present themselves with a sensitive stomach, it is recommended to take the drink with or after a meal to avoid an upset stomach. Participants will repeat this process daily for 6 months/24 weeks (study period) until the study is complete. At week 12 and in week 24, the participants will take a survey and a hormone test to track progress. In total there will be 3 surveys and 3 hormone tests. Additionally, participants will fill out a weekly consumption survey to track compliance. |
| Placebo Drink | Placebo comparator | Dietary Supplement: Placebo DrinkEach day, the participants will take 1 packet of Placebo Drink, dissolved in one glass (8oz+) of water. Placebo Drink may be taken with or without food. Should participants present themselves with a sensitive stomach, it is recommended to take the drink with or after a meal to avoid an upset stomach. Participants will repeat this process daily for 6 months/24 weeks (study period) until the study is complete. At week 12 and in week 24, the participants will take a survey and a hormone test to track progress. In total there will be 3 surveys and 3 hormone tests. Additionally, participants will fill out a weekly consumption survey to track compliance. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- Must be on hormonal birth control (containing both progesterone and estrogen) for the past 6 months \& willing to stop using it to participate in the study
- Must be willing to get off of hormonal birth control for the study period
- Must be able to track their menstrual cycle
- BMI under 40
Key exclusion criteria (11 listed)
- History of oncological (including ovarian cancer) or psychiatric conditions
- History of uncontrolled health conditions
- History of hysterectomy or ovariectomy
- History of diabetes \& thyroid disorders
- Smoker
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 |
|---|---|---|
| PreMama BalancePremama Balance is a blend of the following: Vitex (Chasteberry Extract), commonly used to help regulate hormones; Antioxidants, Selenium, and Magnesium, also help support the cleansing of hormonal birth control from the liver and help strengthen the uterine lining. | Dietary supplement | PreMama Balance |
| Placebo DrinkBlended Placebo drink | Dietary supplement | Placebo Drink |
Primary outcome
Return to perceived regular/normal menstrual cycle
Time frame: 6 Months
Survey Based Assessment of changes in menstrual cycle
Changes in PMS and Menstrual Symptoms: Cramps, Bloating, Mood swings
Time frame: 6 Months
Survey-based assessment of changes in PMS and Menstrual symptoms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Susanne Mitschke principal investigator
Citruslabs
Questions about this trial
What is this clinical trial studying?
A study testing PreMama Balance in people with PMS and Menstrual Discomfort, run by Premama Inc..
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 11 inclusion and 11 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: withdrawn, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Return to perceived regular/normal menstrual cycle (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 3 Apr 2024.