An Investigation of Premama Balance and Its Effects on Hormonal Imbalances

Hormone Disturbance Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05518006
• Other study ID #: 20223
• Status: Withdrawn
• Phase: N/A
• Start date: December 30, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2024
• Source: Premama Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Endocrine System Diseases
• Hormone Disturbance
• Menstrual Discomfort
• Menstrual Irregularity
• Menstrual Pain
• Menstruation Disturbances
• PMS

Intervention

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 Drink
Blended Placebo drink

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Premama Inc.	Citruslabs

Outcome

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