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New treatment option for Menstrual Irregularity
Official title Timing of Energy Availability on Menstrual Cycle Function
ClinicalTrials.gov ID: NCT06471582
What this study is testing
- What it's testing
- The primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length when energy availability is maintained at or above 30 kcal/kg lean body mass/ day among women who regularly do running or cycling exercise. A secondary aim is to determine the effects of fasted prolonged exercise on serum leptin and cortisol.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- participates in structured running or cycling exercise for at least 30 minutes on 3 or more days per week
- accustomed to exercising for 90 minutes or more
- has regular periods every 21-35 days
- have not taken hormonal contraceptives for at least the past 6 months
- is not currently or trying to become pregnant or breastfeeding, and has not been pregnant or breastfeeding in the past 12 months
You likely can't join if
- miss more than 7 consecutive days of aerobic activity (i.e., running, cycling, cross training)
- demonstrate clinical low energy availability as defined as energy availability \<30 kcal/kg fat free mass
- report menstrual cycle lengths \ 35 days in the first 2 months of at-home monitoring
- do not demonstrate an anticipated rise in luteinizing hormone and progesterone in the first 2 months of at-home monitoring
- begin taking a hormonal contraceptive
- become pregnant
See the full eligibility criteria
- participates in structured running or cycling exercise for at least 30 minutes on 3 or more days per week
- accustomed to exercising for 90 minutes or more
- has regular periods every 21-35 days
- have not taken hormonal contraceptives for at least the past 6 months
- is not currently or trying to become pregnant or breastfeeding, and has not been pregnant or breastfeeding in the past 12 months
- does not currently have a diagnosis of a major menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome [PCOS], endometriosis, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)
- does not currently have a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes, congenital adrenal hyperplasia)
- does not currently have a major cardiovascular or respiratory disease
- miss more than 7 consecutive days of aerobic activity (i.e., running, cycling, cross training)
- demonstrate clinical low energy availability as defined as energy availability \<30 kcal/kg fat free mass
- report menstrual cycle lengths \ 35 days in the first 2 months of at-home monitoring
- do not demonstrate an anticipated rise in luteinizing hormone and progesterone in the first 2 months of at-home monitoring
- begin taking a hormonal contraceptive
- become pregnant
- are diagnosed with a menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome [PCOS], endometriosis, ovarian cancer, ovarian insufficiency, uterine, or endometrial cancer)
- are diagnosed with a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)
- are diagnosed with a major cardiovascular or respiratory disease
- are unable to follow instructions for any of the procedures
The study team makes the final eligibility decision.
Where it's taking place
- Colorado Springs, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colorado Springs, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.