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New treatment option for Amenorrhea Secondary
Official title Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women
ClinicalTrials.gov ID: NCT05967819
What this study is testing
- What it's testing
- The goal of this clinical trial is to determine how changes in exercise and psychosocial stress may influence the risk of menstrual cycle irregularities in female runners and cyclists. The main questions it aims to answer are: Does the implementation of exercise or psychosocial stress effect circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length?
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 35, 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 4 days per week or more
- have regular periods every 21 to 35 days
- have not used hormonal contraceptives for at least the past 6 months
- are not currently or trying to become pregnant or are breastfeeding, and have not been pregnant or breastfeeding for the past 12 months
- have never been diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea, dysmenorrhea, polycystic ovary syndrome [PCOS]...
You likely can't join if
- missing \> 4 consecutive days of aerobic exercise (i.e., running, cycling, cross training) if assigned to the exercise intervention groups
- they indicate they "Could not participate at all due to a health problem" or have had to modify their exercise training, felt their injury, illness...
- demonstrate clinical low energy availability as defined as energy availability \<30 Kcal/kg fat free mass in the first two months of at-home...
- report menstrual cycle lengths \ 35 days in the first two months of at-home monitoring
- do not demonstrate an anticipated rise in progesterone levels during the latter half of their cycle and luteinizing hormone levels at mid-cycle...
- begin taking a hormonal contraceptive
See the full eligibility criteria
- participates in structured running or cycling exercise for at least 30 minutes on 4 days per week or more
- have regular periods every 21 to 35 days
- have not used hormonal contraceptives for at least the past 6 months
- are not currently or trying to become pregnant or are breastfeeding, and have not been pregnant or breastfeeding for the past 12 months
- have never been diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea, dysmenorrhea, polycystic ovary syndrome [PCOS], endometriosis, premenstrual dysphoric disorder [PMDD], menstrual migraines...
- have never been diagnosed with a metabolic disease (e.g., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)
- missing \> 4 consecutive days of aerobic exercise (i.e., running, cycling, cross training) if assigned to the exercise intervention groups
- they indicate they "Could not participate at all due to a health problem" or have had to modify their exercise training, felt their injury, illness, or other health problem has affected their exercise performance, or...
- demonstrate clinical low energy availability as defined as energy availability \<30 Kcal/kg fat free mass in the first two months of at-home monitoring
- report menstrual cycle lengths \ 35 days in the first two months of at-home monitoring
- do not demonstrate an anticipated rise in progesterone levels during the latter half of their cycle and luteinizing hormone levels at mid-cycle compared to tests taken during the first few days after menses in the first...
- begin taking a hormonal contraceptive
- become pregnant
- are diagnosed with a menstrual cycle disorder (e.g., menorrhagia, amenorrhea, dysmenorrhea, polycystic ovary syndrome [PCOS], endometriosis, premenstrual dysphoric disorder [PMDD], menstrual migraines, ovarian cancer...
- are diagnosed with a metabolic disease (e.g., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes), 10) are diagnosed with a major cardiovascular disease, respiratory disease, or...
- 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 35 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.