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

Semaine Health

Status

Completed

Conditions

Menstrual Pain

Menstrual Discomfort

Treatments

Dietary Supplement: Semaine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05019924

20216

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts 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)