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An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms

Primary Purpose

Menstrual Pain, Menstrual Discomfort

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Semaine

About this trial

This is an interventional treatment trial for Menstrual Pain focused on measuring PMS, Menstrual symptoms

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Female, aged 18-40
Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study
Ability to take oral medication and be willing to adhere to the dietary supplement regimen
Use of hormonal contraception for at least 3 months prior to screening and agreement to use such a method during study participation. Hormonal contraception must allow for pill bleeds to occur.
Moderate self-reported discomfort during menstruation related to bloating, pelvic cramps, fatigue or mood swings. On a scale of 1-10, participants must report at least a 4 on two or more symptoms.
Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

Current use of GnRH agonists and antagonists including Lupron or Orilissa
Current use of an extended activity hormonal contraception (for example, Depo-provera or Nexplanon)
Current use of hyperthyroid medication such as methimazole
Current use of blood thinning medication
Pregnancy, lactation, or attempting to become pregnant during study
Known allergic reactions to components of the dietary supplement (sunflower oil, ashwagandha, curcumin, resveratrol, Boswellia, milk thistle, quercetin or catechins)

Sites / Locations

Citruslabs

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

Dietary supplement

No intervention given

Outcomes

Primary Outcome Measures

Change in perceived discomfort associated with menstruation [Time Frame: Baseline to 8 weeks)

Perceived discomfort caused by several of the most common menstrual symptoms Cramping Bloating Gastrointestinal issues (diarrhea or constipation) Feeling tired Feeling down emotionally Feeling anxious Headache Each endpoint will be reported by the participant on a scale of perceived discomfort at the end of each menstrual cycle. Participants will complete the surveys for each menstrual cycle. The study uses a questionnaire including a scale from 0-7 to assess the severity of symptoms(0=no symptoms and 7=very severe symptoms). To ensure consistency between participants, each survey will be completed on days 7 or 8 after they stop hormonal contraception usage (or begin placebo pills).

Secondary Outcome Measures

Change in blood biomarkers: C-Reactive Protein (CRP) and 25-hydroxyvitamin D [Time Frame: Baseline to 8 weeks]

Change in C-Reactive Protein (CRP) and 25-hydroxyvitamin D biomarkers measured with an at-home blood test after 8 weeks compared to baseline results.

Full Information

NCT ID

NCT05019924

First Posted

August 10, 2021

Last Updated

March 22, 2022

Sponsor

Semaine Health

Collaborators

Citruslabs

1. Study Identification

Unique Protocol Identification Number

NCT05019924

Brief Title

An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms

Official Title

An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

November 30, 2021 (Actual)

Study Completion Date

November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Semaine Health

Collaborators

Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Dietary supplementation is widely used to alleviate various symptoms of PMS and menstruation such as bloating and cramping. Providing a combination of synergistic dietary supplements is hypothesized to significantly reduce self-reported PMS and menstrual discomfort when compared with a baseline without the intervention.

Detailed Description

This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort. It is hypothesized that the dietary supplement marketed as Semaine PMS & Period Support will improve subjective wellbeing and biomarkers in trial participants. A total of 58 participants will be recruited for the trial following screening, with the expectation that at least 51 will complete the trial. The trial will be fully remote, and all participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle. For both menstrual cycles the participants will complete a subjective wellbeing survey and provide a blood sample for biomarker analysis. The biomarker analysis will be performed through an at-home fingerprick blood test. To maximize consistency, the tests should be performed on the same days of each cycle - preferably on days 4 or 5. If absolutely necessary, however one day of buffer on either side will be allowed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menstrual Pain, Menstrual Discomfort

Keywords

PMS, Menstrual symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention arm

Arm Type

Active Comparator

Arm Description

Dietary supplement

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

No intervention given

Intervention Type

Dietary Supplement

Intervention Name(s)

Semaine

Intervention Description

The dietary supplement is designed, and marketed commercially to be taken in servings of two capsules per day, up to four times per day (a total of 8 capsules daily). Most consumers, however, will only take a serving three times per day, or one with each major meal (breakfast, lunch and dinner).

Primary Outcome Measure Information:

Title

Change in perceived discomfort associated with menstruation [Time Frame: Baseline to 8 weeks)

Description

Time Frame

8 week intervention period

Secondary Outcome Measure Information:

Title

Change in blood biomarkers: C-Reactive Protein (CRP) and 25-hydroxyvitamin D [Time Frame: Baseline to 8 weeks]

Description

Change in C-Reactive Protein (CRP) and 25-hydroxyvitamin D biomarkers measured with an at-home blood test after 8 weeks compared to baseline results.

Time Frame

8 week intervention period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Female, aged 18-40 Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study Ability to take oral medication and be willing to adhere to the dietary supplement regimen Use of hormonal contraception for at least 3 months prior to screening and agreement to use such a method during study participation. Hormonal contraception must allow for pill bleeds to occur. Moderate self-reported discomfort during menstruation related to bloating, pelvic cramps, fatigue or mood swings. On a scale of 1-10, participants must report at least a 4 on two or more symptoms. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration Exclusion Criteria: Current use of GnRH agonists and antagonists including Lupron or Orilissa Current use of an extended activity hormonal contraception (for example, Depo-provera or Nexplanon) Current use of hyperthyroid medication such as methimazole Current use of blood thinning medication Pregnancy, lactation, or attempting to become pregnant during study Known allergic reactions to components of the dietary supplement (sunflower oil, ashwagandha, curcumin, resveratrol, Boswellia, milk thistle, quercetin or catechins)

Facility Information:

Facility Name

Citruslabs

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

This study will be conducted in accordance with the following publication and data sharing policies: the study will be published in an open-access preprint server, and every attempt will be made to publish the results in an open-access peer-reviewed journal. The study administrators (CitrusLabs) will be acknowledged in the publications. This trial will be registered with clinicaltrials.gov and results will be submitted to clinicaltrials.gov following publication.

Learn more about this trial

An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms

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