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NCT05845970 · ClinicalTrials.gov registry record · Phase 1
An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
A Phase 1 study of Premenstrual Syndrome and Menstrual Pain, sponsored by Focus Consumer Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05845970: Completed Phase 1 study of Premenstrual Syndrome and Menstrual Pain, sponsored by Focus Consumer Healthcare.
NCT05845970 is a Phase 1 study of Premenstrual Syndrome and Menstrual Pain that has completed, run by Focus Consumer Healthcare. The registered enrollment target is 100 participants, below the 118-participant average among 6 other Premenstrual Syndrome trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05845970, a Phase 1 study of Premenstrual Syndrome and Menstrual Pain, has completed, sponsored by Focus Consumer Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Menstrual cycle symptoms will be measured via study-specific questionnaires.
Conditions Studied
Interventions
- OTHER Pamprin Botanicals
- COMBINATION_PRODUCT Pamprin Botanicals + Pamprin Menstrual Pain Relief
Study Locations (1)
California
- Citruslabs - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-02-08 |
| Est. Completion | 2023-07-01 |
| Phase | Phase 1 |
What the finished NCT05845970 record still lists
NCT05845970 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 118-participant average among 6 other Premenstrual Syndrome trials with a reported enrollment target (15% lower).
The record links to 2 conditions, with Premenstrual Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Pamprin Botanicals is the first listed.
NCT05845970 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05845970 about?
NCT05845970 is a clinical study titled "An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief". 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 wi...
What is the current status of trial NCT05845970?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2023-02-08. Estimated completion is 2023-07-01.
What conditions does trial NCT05845970 study?
This clinical trial studies the following conditions: Premenstrual Syndrome, Menstrual Pain.
What interventions are being tested in trial NCT05845970?
The interventions under investigation include: Pamprin Botanicals (OTHER), Pamprin Botanicals + Pamprin Menstrual Pain Relief (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05845970?
This trial is sponsored by Focus Consumer Healthcare, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05845970 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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