Clinical trials

6

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Timing of Energy Availability on Menstrual Cycle Function

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. Participants will be asked to do the following over a \~3 month enrollment period: * attend a laboratory visit at the beginning of the study to have their resting metabolic rate, aerobic fitness, and body composition tested * monitor their menstrual cycle length, urine hormones, perceived stress levels, and diet for \~3 months * complete 3, 90-minute exercise sessions on a stationary bike or treadmill either fed (consuming a carbohydrate meal 1 h prior and 0.7 g carbohydrate/ kg body mass/ h during exercise) or fasted (consuming no meal prior and no carbohydrates during exercise) during month \~3 * saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol

Participants needed: 64
Trial details
Age: 18-40Biological sex: FemaleType: InterventionalSponsor: University of Colorado, Colorado SpringsUpdated: May 1, 2026Locations: 1
Eligibility criteria

participates in structured running or cycling exercise for at least 30 minutes o... [+7]

miss more than 7 consecutive days of aerobic activity (i.e., running, cycling, c... [+9]

Status: Recruiting

The Effectiveness of Emergency Room Protocols for Treating Hyperthermia

This study will help us as scientists and clinicians understand how effective commonly used cooling protocols in emergency departments are and which of the protocols is the most effective. It consists of a single, approximately 1 hour preliminary session and five, approximately 3 hour experimental sessions, equaling an approximate 16 hour total time commitment. The purpose of this research is to test the effectiveness of three cooling protocols. 1. Cooling packs 2. "Ice Sheets", which are bed sheets soaked in ice water, wrapped around the participant, while a fan blows air on them. 3. Body bag filled with ice, commonly used in emergency departments to treat hyperthermia Additionally, a negative control (passive cooling in air-conditioned room) and a positive control (cold water immersion).

Participants needed: 50
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: University of Colorado, Colorado SpringsUpdated: Feb 25, 2026Locations: 1
Eligibility criteria

Active, healthy individuals

Pregnant or planning on becoming pregnant [+4]

Status: Recruiting

Effects of Physical and Psychosocial Stress on Functional Hypothalamic Amenorrhea in Exercising Women

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? * Is there an additive effect of combined exercise and psychosocial on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length? Participants will be asked to do the following over the \~3 month enrollment period: * attend a laboratory visit at the beginning and end of the study to have their resting metabolic rate, aerobic fitness, and body composition tested * monitor their menstrual cycle length, daily perceived stress levels, physical activity, and diet each month * provide several urine and saliva samples each month * either maintain their usual physical activity and lifestyle habits (control group), increase the duration of their weekly running or cycling mileage by 30% (exercise stress group), complete cognitive function tasks designed to be stressful (psychosocial stress group), or increase the duration of their weekly running or cycling mileage by 30% and complete cognitive function tasks designed to be stressful (exercise + psychosocial stress group) during the final month of enrollment. Researchers will compare control, exercise stress, psychosocial stress, and exercise + psychosocial stress groups to see if there is an effect on circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length.

Participants needed: 54
Trial details
Age: 18-35Biological sex: FemaleType: InterventionalSponsor: University of Colorado, Colorado SpringsUpdated: Jan 8, 2026Locations: 1
Eligibility criteria

participates in structured running or cycling exercise for at least 30 minutes o... [+5]

missing > 4 consecutive days of aerobic exercise (i.e., running, cycling, cross... [+9]

Status: Recruiting

Moderate Aerobic Exercise for Managing Menstrual Cycle Symptoms

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.

Participants needed: 35
Trial details
Age: 18-40Biological sex: FemaleType: InterventionalSponsor: University of Colorado, Colorado SpringsUpdated: Jul 24, 2025Locations: 1
Eligibility criteria

premenopausal (defined as having regular menstrual periods every 21-35 days) [+5]

becoming physically active defined as scoring higher than "low activity/inactive... [+5]

Status: Recruiting

The Healthy Families Bright Futures Program

The goal of this clinical trial is to learn about an online group program (Healthy Families Bright Futures program) for LGBTQ+ teens and their caregivers. The main question\[s\] it aims to answer are: • is this program acceptable, appropriate, and feasible for LGBTQ+ youth and their caregivers • does the program affect teen (alcohol use, dating violence, alcohol use refusal self-efficacy, healthy communication self-efficacy) and caregiver (accepting behaviors, parenting self-efficacy, parenting behaviors) outcomes associated with risk for dating violence and alcohol use among LGBTQ+ teens. Participants will participate in a one-hour weekly online group for seven weeks with separate groups for teens and caregivers.

Participants needed: 160
Trial details
Age: 15-18Biological sex: AllType: InterventionalSponsor: University of Colorado, Colorado SpringsUpdated: Jul 17, 2025Locations: 1
Eligibility criteria

Age between 15 and 18 years [+7]

Current enrollment as a college student [+3]

Status: Recruiting

Improving Maternal Sleep and Mental Health

The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]: Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU. Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.

Participants needed: 342
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: University of Colorado, Colorado SpringsUpdated: Feb 10, 2025Locations: 1
Eligibility criteria

Pregnant women with a singleton gestation who have a military affiliation [+5]

Presence of depression assessed over the phone using the Structured Clinical Int... [+6]