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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT05587920
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-40 years old
2. No hormonal contraceptive use (with regular menstrual cycles 24-35 days in length, and have not been taking any hormonal contraceptives for at least 12 months), or;
3. Use of the combined oral contraceptive pill containing ≥25 mg ethinyl-oestradiol (EE) and an anti/low androgenic progestin for at least 12 months, or;
4. Use of the hormonal coil (IUS) continuously for at least 2 years, or;
5. Use of the hormonal implant continuously for at least 2 years, or;
6. Use of the hormonalDMPA injection continuously for at least 2 years;
7. Weight stable (no change in self-reported body mass ≥ 5% over the previous 3 months);
8. BMI between 18 and 30 kg·m2.
Exclusion Criteria:
1. Taking a hormonal contraceptive other than the combined oral contraceptive pill containing ≥25 mg EE and an anti/low androgenic progestin, hormonal coil (IUS), the hormonal contraceptive implant or the DMPA hormonal injection;
2. History of DMPA hormonal injection use in those women not currently using the DMPA hormonal injection;
3. Diagnosed Premature Ovarian Insufficiency;
4. Pregnancy;
5. Less than 2 years postpartum;
6. Given birth to more than 2 children;
7. Evidence of disordered eating (≥ 20 on the EAT-26);
8. Any self-diagnosed eating disorder;
9. Self-reported change in body mass of ≥ 5% over the previous 3 months;
10. Body mass index of \< 18 or \> 30 kg·m2;
11. Evidence of menstrual disturbance (oligomenorrhea: \< 9 menstrual cycles in previous 12 months or amenorrhoea: ≤ 3 menstrual cycles in the previous 12 months);
12. Habitual smoking (regularly smoking more than 10 cigarettes per day);
13. Taking any medications known to affect bone or calcium metabolism (e.g., treatment for thyroid disorders).
14. Total 25-hydroxyvitamin D (25(OH)D)level \< 30 nmol/l at baseline, confirmed with a venous blood sample;
15. Self-declared history of heart, liver or kidney disease, diabetes, or thyroid disorder;
16. Self-reported bone fracture in the previous 12 months.
Exclusion Criteria for Reference Point Indentation Only:
1. Local oedema;
2. Local skin infection or cellulitis;
3. Prior clinical or stress fracture in the tibial diaphysis;
4. Dermatological lesions around the measurement site;
5. Focal tibial lesions like in primary or metastatic tumour, Paget's disease, Gaucher;
6. Osteomyelitis of the tibia;
7. Systemic infection or fever (unless unrelated to infection);
8. Allergy to lidocaine.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05587920
Study Brief:
Protocol Section:
NCT05587920