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

NCT05845970 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-29

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Focus Consumer Healthcare

    lead INDUSTRY

  • Citruslabs

    collaborator INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-08
Primary Completion
2023-06-01
Completion
2023-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845970 on ClinicalTrials.gov