An Investigation of Premama Balance and Its Effects on Hormonal Imbalances

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.

Study Overview

• Status: Withdrawn
• Conditions: Menstrual Irregularity; Menstrual Pain; Hormone Disturbance; PMS; Menstrual Discomfort
• Intervention / Treatment: Dietary supplement: PreMama Balance; Dietary supplement: Placebo Drink

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• 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)

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PreMama Balance; 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.	Dietary supplement: PreMama Balance; 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 Comparator: Placebo Drink; 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.	Dietary supplement: Placebo Drink; Blended Placebo drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to perceived regular/normal menstrual cycle	Survey Based Assessment of changes in menstrual cycle	6 Months
Changes in PMS and Menstrual Symptoms: Cramps, Bloating, Mood swings	Survey-based assessment of changes in PMS and Menstrual symptoms	6 Months

Collaborators and Investigators

• Sponsor: Premama Inc.
• Collaborators: Citruslabs
• Investigators: Principal Investigator: Susanne Mitschke, Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PMS; Menstrual Discomfort; Hormone Disturbance; Menstrual Pain; Menstrual Irregularity
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pelvic Pain; Menstruation Disturbances; Dysmenorrhea; Endocrine System Diseases
• Other Study ID Numbers: 20223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No