CompletedNot Applicable

A Randomized Placebo-Controlled Study to Evaluate the Effects of a Gummy and Capsule Supplement on Symptoms of Premenstrual Syndrome

United States176 participantsStarted 2024-09-04

Plain-language summary

This virtual, randomized, placebo-controlled clinical trial evaluates the effectiveness of a PMS capsule and PMS gummy in alleviating premenstrual syndrome symptoms over 12 weeks. Participants will be divided into four groups, receiving either the PMS capsule, capsule placebo, PMS gummy, or gummy placebo. Efficacy will be assessed using validated questionnaires.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female 18+ years of age. * Must be in good health with no significant chronic conditions (such as oncological or psychiatric disorders) and a BMI under 35. * Must experience at least five of the following symptoms during their menstrual cycle: Menstrual pain, Menstrual cramping, Increased Irritability, Mood changes, Breast tenderness, Headaches/migraines, Bloating, Fatigue, Constipation or diarrhea, Sleep disturbances * Must have a regular menstrual cycle with a bleed week, and must be currently tracking their menstrual cycle and able to accurately predict their bleed week. * If using hormonal contraception, must do so for at least three months before starting the trial, and remain consistent with taking it as per healthcare provider instructions during the study. * If using hormonal contraception, must allow for a bleed week every month. * Must agree to avoid cannabis, CBD, ashwagandha, and supplements other than multivitamins or protein powders for 24 hours prior to the study, and during the full study duration. * Willing to refrain from OTC pain medications or supplements to target period-related symptoms during the study period. * Must live in the United States. Exclusion Criteria: * Suffers from pre-existing conditions that would prevent them from adhering to the protocol. * Anyone currently undergoing or planning to undergo during the study period, any gynecological-related procedures. * Anyone diagnosed with Graves disease, Hashimotos or taki…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Premenstrual Syndrome (PMS) Symptom Severity

Timeframe: From baseline to Day 5 of Cycle 2 (approximately 8 weeks after baseline)

Trial details

NCT IDNCT06763809

SponsorSemaine Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-12

View on ClinicalTrials.gov More PMS trials