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An Investigation of Premama Balance and Its Effects on Hormonal Imbalances

Primary Purpose

PMS, Menstrual Discomfort, Hormone Disturbance

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PreMama Balance
Placebo Drink
Sponsored by
Premama Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PMS focused on measuring PMS, Menstrual Discomfort, Hormone Disturbance, Menstrual Pain, Menstrual Irregularity

Eligibility Criteria

20 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    PreMama Balance

    Placebo Drink

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 24, 2022
    Last Updated
    August 24, 2022
    Sponsor
    Premama Inc.
    Collaborators
    Citruslabs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05518006
    Brief Title
    An Investigation of Premama Balance and Its Effects on Hormonal Imbalances
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Premama Inc.
    Collaborators
    Citruslabs

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PMS, Menstrual Discomfort, Hormone Disturbance, Menstrual Pain, Menstrual Irregularity
    Keywords
    PMS, Menstrual Discomfort, Hormone Disturbance, Menstrual Pain, Menstrual Irregularity

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PreMama Balance
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo Drink
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    PreMama Balance
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo Drink
    Intervention Description
    Blended Placebo drink
    Primary Outcome Measure Information:
    Title
    Return to perceived regular/normal menstrual cycle
    Description
    Survey Based Assessment of changes in menstrual cycle
    Time Frame
    6 Months
    Title
    Changes in PMS and Menstrual Symptoms: Cramps, Bloating, Mood swings
    Description
    Survey-based assessment of changes in PMS and Menstrual symptoms
    Time Frame
    6 Months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patrick Renner
    Phone
    4242450284
    Email
    hello@citruslabs.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susanne Mitschke
    Organizational Affiliation
    Citruslabs
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    An Investigation of Premama Balance and Its Effects on Hormonal Imbalances

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