Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will determine whether the negative effects of combined oral contraceptive (COC) therapy on the growth hormone/insulin-like growth factor-1 (GH/IGF-1) axis and bone turnover are dependent on the route of administration such that an attenuation of these effects is observed when a comparable dose of non-oral transdermal contraceptive (TDC) and contraceptive vaginal ring therapy (CVR) are also tested.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Penn State University
• Collaborators: Massachusetts General Hospital; Purdue University
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Ethinyl Estradiol; NuvaRing

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)