An Investigation of Premama Balance and Its Effects on Hormonal Imbalances

Not Applicable

Withdrawn

• Conditions: Menstrual Irregularity; PMS; Menstrual Discomfort; Hormone Disturbance; Menstrual Pain

• Registration Number: NCT05518006
• Lead Sponsor: Premama Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-12-30
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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