An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief

NCT05845970 | Completed Phase 1 FDA Drug

• 1 other identifier: 20268
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Women often experience significant pain during their periods which can significantly impact on quality of life. In this study, two products that are used to alleviate period pain will be examined. One test product is botanically based, and the other is a traditional over-the-counter pain reliever with additional components added to support less painful periods. The trial will be a cross-over trial where participants will use the botanical product before, during, and after their first period. Participants will use the botanical product alongside a traditional over-the-counter period product during their second period. Participants will answer surveys and have blood drawn at a third-party lab to answer the main objectives of this trial.

Conditions

Menstrual Pain; Premenstrual Syndrome

Outcome Measures

Primary Outcomes (1)

• Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]

  Menstrual cycle symptoms will be measured via study-specific questionnaires.

  60 days

Secondary Outcomes (1)

• Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 60 days)]

  60 days

Study Arms (1)

Single Group

EXPERIMENTAL

Single-group crossover trial with 100 total participants. Participants will use Pamprin Botanicals during their first period and both Pamprin Botanicals and over-the-counter Pamprin Menstrual Relief during their second period.

Other: Pamprin Botanicals; Combination Product: Pamprin Botanicals + Pamprin Menstrual Pain Relief

Interventions

Pamprin Botanicals OTHER

Participants will take Pamprin Botanicals only. Participants will take 450mg of Pamprin Botanicals two days before their predicted period and then take it every day during their period. Participants can also take Pamprin Botanicals two days after the bleeding has concluded.

Single Group

Pamprin Botanicals + Pamprin Menstrual Pain Relief COMBINATION_PRODUCT

Participants will repeat taking Pamprin Botanicals two days before their second predicted period and continue to take it each day during their period. However, during the second period, participants will also take Pamprin Menstrual Pain Relief per the over-the-counter directions (2 tablets every 6 hours with water).

Single Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female between 18-40 years of age.
• Must be in good health with no significant chronic conditions and a BMI under 35.
• Must experience period pain and other PMS symptoms.
• Must have a regular menstrual cycle with a bleed week.
• If using hormonal contraception, must do so for at least three months
• If using oral contraception, must allow for bleed week.
• Must be able to predict their bleed week.
• Willing to abstain from strenuous exercise 24 hours before each of the three blood draws in this trial.

You may not qualify if:

• Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
• Anyone with known severe allergic reactions.
• Anyone with a previous negative experience with acetaminophen.
• Unwilling to follow the study protocol.
• Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.
• Anyone who uses other supplements for period pain and PMS symptoms.
• Current use of an extended activity hormonal contraception (examples include Depo-provera or Nexplanon.

Sponsors & Collaborators

• Focus Consumer Healthcare: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 09404, United States

Location

MeSH Terms

Conditions

Dysmenorrhea; Premenstrual Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 6, 2023
• Study Start: February 8, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

US (1)