Menstrual PainPhase 1NCT05845970
An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
A Phase 1 study testing Pamprin Botanicals and Pamprin Botanicals + Pamprin Menstrual Pain Relief in people with Menstrual Pain and Premenstrual Syndrome, run by Focus Consumer Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Pain, Premenstrual Syndrome
- What is being tested?
- Pamprin Botanicals and Pamprin Botanicals + Pamprin Menstrual Pain Relief
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 1 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Pamprin Botanicals, Pamprin Botanicals + Pamprin Menstrual Pain Relief
- Medical subject headings
- Dysmenorrhea, Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pamprin BotanicalsOther
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.
Pamprin Botanicals + Pamprin Menstrual Pain ReliefCombination 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pamprin Botanicals; Combination Product: Pamprin Botanicals + Pamprin Menstrual Pain Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]
Menstrual cycle symptoms will be measured via study-specific questionnaires.
Measured: 60 days
Secondary outcomes (1)
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start8 Feb 2023
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Focus Consumer Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845970
- Sponsor's protocol ID
- 20268
- Status last verified
- Feb 2024
- First submitted
- 3 Apr 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
- ClinicalTrials.gov ID
- NCT05845970
- Acronym / sponsor ID
- 20268
- Conditions
- Menstrual Pain, Premenstrual Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Focus Consumer HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Other: Pamprin Botanicals, Combination Product: Pamprin Botanicals + Pamprin Menstrual Pain ReliefSingle-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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pamprin BotanicalsParticipants 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. | Other | Single Group |
| Pamprin Botanicals + Pamprin Menstrual Pain ReliefParticipants 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). | Combination product | Single Group |
Primary outcome
Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]
Time frame: 60 days
Menstrual cycle symptoms will be measured via study-specific questionnaires.
1 secondary outcome
Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 60 days)]
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pamprin Botanicals and Pamprin Botanicals + Pamprin Menstrual Pain Relief in people with Menstrual Pain and Premenstrual Syndrome, run by Focus Consumer Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)] (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.