Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT02367833
Eligibility Criteria:
Inclusion Criteria:
1. Female
2. Age 18-30 yrs
3. BMI 18-29 kg/m2
4. Non-smoking
5. Not using hormonal contraceptives for at least 6 months prior
6. Not currently pregnant nor intending to become pregnant in the next 6 months
7. Not lactating
8. No apparent metabolic, endocrine, musculoskeletal, or severe psychiatric disease
9. Willing to adhere to maintenance of current exercise training and diet and remain weight stable (±2 kg) during study
10. Variable physical activity acceptable, but mode must be primarily weight bearing
11. At least 9 menses in past 12 months
12. Willing to quit taking any current nutritional supplements and take Calcium and Vitamin D supplements for the duration of the study.
13. If 21 or older, a normal Pap smear must be confirmed.
Exclusion Criteria:
1. Non-weight bearing exercise as primary mode of physical activity
2. Known or suspected metabolic or endocrine disease
3. Pregnant
4. Currently consuming large amounts of soy products
5. Regular consumption of grapefruit juice
6. Current clinical eating disorder or other axis 1 psychiatric or bipolar disorders
7. Oral or hormonal contraceptive use in the last 6 months
8. Currently amenorrheic
9. Hyperparathyroidism
10. Liver or renal disease
11. Evidence of malabsorption or skeletal disorder
12. Thyroid abnormalities (controlled hypothyroidism acceptable)
13. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDS)
14. Taking medications known to have interactions with contraceptive therapy
15. Division I Athlete, on or off season
16. Other Exclusion Criteria proposed by the World Health Organization COC Contraindications (Grossman, 2011)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT02367833
Study Brief:
Protocol Section:
NCT02367833