NCT05845970

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Focus Consumer Healthcare · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Pamprin Botanicals	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.
COMBINATION_PRODUCT	Pamprin Botanicals + Pamprin Menstrual Pain Relief	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).

Timeline

• Start date: 2023-02-08
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2023-05-06
• Last updated: 2024-02-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study