A Phase 1 interventional study of Pamprin Botanicals and Pamprin Botanicals + Pamprin Menstrual Pain Relief in Menstrual Pain and Premenstrual Syndrome, sponsored by Focus Consumer Healthcare. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Focus Consumer Healthcare · Phase 1, Interventional, and Treatment
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.
177 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.
This study's enrollment of 100 is above the median of 70 across 153 interventional studies indexed under Premenstrual Syndrome.
Browse Premenstrual Syndrome studies →Focus Consumer Healthcare is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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).
Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]
Menstrual cycle symptoms will be measured via study-specific questionnaires.
Time frame: 60 days
Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 60 days)]
hs-CRP and cortisol will be measured via blood draws. Blood draws will occur at Baseline, Day 5 of bleeding during their first menstrual cycle during the study, and Day 5 of bleeding during their second menstrual cycle during the study.
Time frame: 60 days
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Focus Consumer Healthcare