- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267728
A Clinical Study to Assess the Effect of a Dietary Supplement on Menstrual Cycle Symptoms
November 25, 2025 updated by: Muse Nutrition Ltd
This is a single-group, virtual clinical trial evaluating the effects of a daily dietary supplement (DITTO Cycle Supplement) on menstrual cycle symptoms across three menstrual cycles.
The study investigates changes in symptom severity and quality of life through validated questionnaires including the Menstrual Symptoms Questionnaire (MSQ).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89118
- Citruslabs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female-at-birth
- Aged 18-45
- In the last three menstrual cycles, has experienced three or more of the following symptoms associated with their menstrual cycle: Menstrual cramps, Bloating, Breast tenderness, Headaches, Fatigue, Muscle aches and/or joint pain, Cravings, Mood swings, Low mood, Feelings of anxiety, Irritability, Difficulty concentrating
- Generally healthy - does not live with any uncontrolled chronic disease
- Has a regular menstrual cycle length, between 23 and 35 days
- Tracks their menstrual cycle and can predict their period dates
- Anyone willing to comply with study requirements
- Anyone with no known allergies to the ingredients listed in the product
Exclusion Criteria:
- Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Women who are pregnant, breastfeeding, or trying to conceive
- Anyone unwilling to follow the study protocol
- Anyone in perimenopause, menopause, or experiencing menopausal-type symptoms
- Anyone with planned surgery during the study period
- Anyone with a history of substance abuse
- Anyone diagnosed with high blood pressure, high cholesterol, heart disease, heart attack, stroke, irregular heartbeat (AFib), clogged arteries, poor circulation, heart failure, or other heart conditions
- Anyone diagnosed with a hormone or reproductive health-related cancer or benign condition
- Anyone diagnosed with a menstrual health condition such as endometriosis, PCOS, or adenomyosis
- Anyone diagnosed with diabetes or other endocrine-related condition
- Anyone currently participating or planning to participate in a research study
- Anyone who has started, changed, or stopped taking hormonal birth control in the last three months
- Has a planned insertion or replacement of an IUD in the next 12 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DITTO Cycle Supplement
Participants will take two capsules of the DITTO Cycle Supplement once daily, starting two days after menstrual bleeding ends, for the duration of three menstrual cycles.
|
The capsules should be taken in the morning with the first meal and a glass of water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Menstrual Symptoms Questionnaire (MSQ) Scores
Time Frame: Baseline, End of Cycle 1(28 days), End of Cycle 2(28 days), End of Cycle 3 (28 days)
|
Change from baseline in menstrual symptom severity as measured by the Menstrual Symptoms Questionnaire (MSQ), including cramps, bloating, fatigue, mood swings, breast tenderness, headaches, anxiety, irritability, and difficulty concentrating.
|
Baseline, End of Cycle 1(28 days), End of Cycle 2(28 days), End of Cycle 3 (28 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Menstrual-Related Quality of Life
Time Frame: Baseline, End of Cycle 1(28 days), End of Cycle 2(28 days), End of Cycle 3 (28 days)
|
Change from baseline in participant-reported quality of life related to menstrual symptoms, measured using study-specific self-report questionnaires evaluating overall impact on daily living and well-being.
|
Baseline, End of Cycle 1(28 days), End of Cycle 2(28 days), End of Cycle 3 (28 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2025
Primary Completion (Actual)
July 1, 2025
Study Completion (Actual)
July 1, 2025
Study Registration Dates
First Submitted
November 19, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
November 25, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20736
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Menstrual Pain
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Not yet recruitingAdolescent | Dysmenorrhea | mHealth | Heavy Menstrual Bleeding | Menstrual Discomfort | Mobile Application | Menstrual Cycle Abnormal | Menstrual Cramps | Menstrual Disorder | Menstrual Health Intervention | Menstrual Bleeding, Heavy | Menstrual HealthNetherlands
-
Premama Inc.CitruslabsWithdrawnMenstrual Irregularity | Menstrual Pain | Hormone Disturbance | PMS | Menstrual Discomfort
-
Semaine HealthCitruslabsCompletedMenstrual Pain | Menstrual DiscomfortUnited States
-
Bulent Ecevit UniversityNot yet recruitingMuscle Strength | Menstrual Pain | Menstrual Disorders
-
Cynthia del Rocío Márquez BeltránUniversity of HuelvaCompletedPrimary Dysmenorrhea | Menstrual Pain | Menstrual Distress \(Dysmenorrhea\)Spain
-
Your Super, INC.CitruslabsCompletedMenstrual Pain | PMS | Menstrual DiscomfortUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Active, not recruitingDysmenorrhea | Menstrual Cycle | Menstrual Pain | Mobile Health | Heavy Menstrual Bleeding | Menstrual Cramps | Menstrual Distress (Dysmenorrhea) | Daily Activities | Menstrual Health Intervention | Mobile Health Technology (mHealth)Netherlands
-
University of British ColumbiaCompletedPerimenopause | Menstrual CrampsCanada
-
My Happy FloCitruslabsCompletedFatigue | Women's Health | Menstrual CrampsUnited States
-
Kevin HellmanNot yet recruiting
Clinical Trials on DITTO Cycle Supplement
-
Texas Woman's UniversityCompleted
-
Loughborough UniversityKyowa Hakko Bio Co., Ltd.CompletedDietary ExposureUnited Kingdom
-
Shenzhen TargetRx, Inc.The First Affiliated Hospital of Bengbu Medical UniversityCompleted
-
Institute for Clinical Effectiveness and Health...Ministry of Public Health, ArgentinaCompletedCardiovascular Diseases | Quality ImprovementArgentina
-
Riphah International UniversityRecruitingCystic Fibrosis (CF)Pakistan
-
State University of New York at BuffaloUnited States Department of DefenseRecruitingHyperthermia | Fatigue; HeatUnited States
-
Clinique MathildeCompleted
-
Cairo UniversityNot yet recruitingPeripheral Arterial Disease
-
Shriners Hospitals for ChildrenCompletedSpinal Cord InjuryUnited States
-
Wake Forest University Health SciencesCompleted