NCT05019924

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Semaine Health · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menstrual Pain
• Menstrual Discomfort

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Semaine	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).

Timeline

• Start date: 2021-08-01
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2021-08-25
• Last updated: 2022-03-24

Locations

1 site across 1 country: United States