ClinicalTrials.gg
RecruitingNCT07084714Updated Jul 24, 2025

Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms

An interventional study of Moderate Aerobic Exercise in Premenstrual Syndrome, Menstrual Cycle and Menstrual Distress (Dysmenorrhea), sponsored by University of Colorado, Colorado Springs. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-07-24.

Sponsored by University of Colorado, Colorado Springs · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

The goal of this clinical trial is to evaluate the impact of moderate aerobic exercise on menstrual symptom management in sedentary women both using and not using hormonal contraceptives. The main questions it aims to answer are:

Is there a reduction in physical and/or psychological menstrual cycle related symptom burden with participation in moderate aerobic exercise for sedentary women using and not using hormonal contraceptives?

Is there a difference in physical and/or psychological menstrual cycle related symptom burden between hormonal contraceptive and non-hormonal contraceptive users?

Is a moderate aerobic exercise intervention more effective in reducing physical and/or psychological menstrual related symptom burden for sedentary women using or not using hormonal contraceptives?

Participants will:

  • Have their body composition assessed using dual energy X-ray absorptiometry pre and post exercise intervention.
  • Complete a Menstrual Symptom Index (MSi) to report daily menstrual cycle related symptom burden in addition to the Premenstrual Symptom Screening Tool (PSST) and Heavy Menstrual Bleeding (HMB) questionnaire monthly.
  • Utilize an at-home monitor to test urinary luteinizing hormone, estrone-3-glucuronide, and pregnanediol glucuronide approximately 10 times per month and report menstrual cycle length.
  • Record physical activity habits by continuously wearing a wrist-based accelerometer and chest-strap heart rate monitor during planned aerobic exercise sessions and complete the International Physical Activity Questionnaire (IPAQ) monthly.
  • Maintain their usual sedentary activity habits for one menstrual cycle followed by completion of an exercise intervention designed to progress individuals to meet minimum recommended aerobic physical activity guidelines of 150 minutes per week set by the American College of Sports Medicine for two menstrual cycles.
02

Conditions studied

  • Premenstrual Syndrome
  • Menstrual Cycle
  • Menstrual Distress (Dysmenorrhea)
  • Menstrual Bleeding, Heavy

Keywords

  • menstrual cycle
  • premenstrual syndrome
  • dysmenorrhea
03

In context

Premenstrual Syndrome

177 studies on the registry are indexed under Premenstrual Syndrome; 32 are open to participants now.

This study's planned enrollment of 35 is below the median of 70 across 154 interventional studies indexed under Premenstrual Syndrome.

Browse Premenstrual Syndrome studies →

Lead sponsor

University of Colorado, Colorado Springs is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • premenopausal (defined as having regular menstrual periods every 21-35 days)
  • either not using hormonal or non-hormonal (i.e., intrauterine device) for the past 6 months OR using combined oral contraceptives (i.e., those that contain progesterone and estrogen) for at least the past 6 months
  • not currently pregnant or trying to become pregnant
  • sedentary lifestyle (score of "low activity/inactive" assessed using the IPAQ)
  • have self reported menstrual cycle symptoms (symptoms reported on the PSST or MSi)
  • do not have a medical diagnosis or signs/symptoms of diabetes, cardiovascular, or renal disease and are able to participate in moderate intensity physical activity without physician clearance

Exclusion criteria

Exclusion Criteria:

  • becoming physically active defined as scoring higher than "low activity/inactive" on the IPAQ during the first month of the study
  • non compliance with instructions provided for the moderate aerobic exercise intervention (i.e., not adhering to predetermined intensity heart rate targets) or miss more than 25% of exercise sessions in either intervention month
  • becoming pregnant during enrollment
  • being diagnosed with a cardiovascular, metabolic, or renal disease that would require physical clearance to participate in moderate intensity aerobic physical activity
  • begin using hormonal or non-hormonal (i.e., intrauterine devices) if assigned to the arm not using hormonal contraceptives
  • either begin a different type of contraceptive or discontinue combined hormonal contraceptive use if assigned to the hormonal contraceptive arm
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Non-hormonal contraceptive users

    Women who report regular menstrual periods every 21-35 days and have not used hormonal or non-hormonal (i.e., intrauterine device) contraceptives in the past 6 months.

    Behavioral: Moderate Aerobic Exercise

  • Experimental
    Hormonal contraceptive users

    Women who are taking a combined oral contraceptive (i.e., those that contain a form of progesterone and estrogen) for at least the past 6 months.

    Behavioral: Moderate Aerobic Exercise

Interventions

  • BehavioralModerate Aerobic Exercise

    Participants will complete moderate intensity aerobic exercise for 30 minutes per session, progressing from three to five days per week to meet the minimum recommended aerobic physical activity guideline of 150 minutes per week set by the American College of Sports Medicine (ACSM) over two menstrual cycles. Moderate intensity is defined as maintaining a heart rate within 40-59% heart rate reserve and a rate of perceived exertion of 11-14 "light to somewhat hard" on the Borg 6-20 scale.

06

What researchers measure

Primary outcomes

  1. Change from baseline in Menstrual Symptom Index (MSi) scores

    The MSi asks participants to report the intensity they are experiencing 18 menstrual related symptoms on a scale ranging from 0 = "do not feel at all" to 3 = "intense." A score of 0 indicates no symptom burden and 54 the maximum symptom burden.

    Time frame: Baseline, 1 month, and 2 months

  2. Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Symptoms

    The PSST has participants report the intensity which they experience 14 premenstrual symptoms on a scale ranging from 0 = "not at all" to 3 = "intense". A score of 0 reflects no premenstrual symptom burden and a score of 42 indicates maximal premenstrual symptom burden.

    Time frame: Baseline, 1 month, 2 month

  3. Change from baseline in Premenstrual Symptoms Screening Tool (PSST) - Quality of Life

    The PSST asks participants to report the severity by which premenstrual symptoms affect 4 functional aspects of life related to work, relationships with coworkers and family, and home responsibilities on a scale ranging from 0 = "not at all" to 3 = "severe". A score of 0 indicates no interference and 12 maximal interference.

    Time frame: Baseline, 1 month, 2 months

Other outcomes

  1. Urinary luteinizing hormone (LH)

    mIU/mL

    Time frame: Baseline, month 1, month 2

  2. Urinary pregnanediol glucuronide (PdG)

    ug/mL

    Time frame: Baseline, 1 month, 2 months

  3. Urinary estrone-3-glucuronide (E3G)

    ng/mL

    Time frame: Baseline, month 1, month 2

07

Study locations

1 of 1 sites recruiting
  • William J. Hybl Sports Medicine and Performance Center
    Colorado Springs, Colorado 80918, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07084714
Lead sponsor
University of Colorado, Colorado Springs
Responsible party
Marissa Baranauskas (Assistant Professor, University of Colorado, Colorado Springs) — Principal investigator
First posted
Jul 24, 2025
Start date
Jul 2025 (estimated)
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Jul 24, 2025

Study contacts

Marissa Baranauskas, PhD
Contact
mbaranau@uccs.edu
719-255-4475

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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