An Investigation of Premama Balance and Its Effects on Hormonal Imbalances

NCT05518006 | Withdrawn

• 1 other identifier: 20223
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

PMS; Menstrual Discomfort; Hormone Disturbance; Menstrual Pain; Menstrual Irregularity

Keywords

PMS; Menstrual Discomfort; Hormone Disturbance; Menstrual Pain; Menstrual Irregularity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Dietary Supplement: Placebo Drink

Interventions

PreMama Balance DIETARY_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.

PreMama Balance

Placebo Drink DIETARY_SUPPLEMENT

Blended Placebo drink

Placebo Drink

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Premama Inc.: lead
• Citruslabs: collaborator

MeSH Terms

Conditions

Endocrine System Diseases; Dysmenorrhea; Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Susanne Mitschke

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: December 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04