Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis
Condition: Bone; Disorder, Development and Growth
MeSH terms: Bone Diseases
Intervention: Combined Oral Contraceptive; Transdermal Contraceptive; Contraceptive Vaginal Ring
Intervention description: The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral and non-oral ethinyl estradiol on the GH/IGF-1 axis and bone metabolism. Using a prospective repeated measures design, we will test the effects of 2 cycles of combined oral contraceptive (Apri or Reclipsen) on the GH/IGF-1 axis.; The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral and non-oral ethinyl estradiol on the GH/IGF-1 axis and bone metabolism. Using a prospective repeated measures design, we will test the effects of 2 cycles of a transdermal contraceptive (Xulane) on the GH/IGF-1 axis.; The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral and non-oral ethinyl estradiol on the GH/IGF-1 axis and bone metabolism. Using a prospective repeated measures design, we will test the effects of 2 cycles of vaginal ring contraceptive (Nuva Ring) on the GH/IGF-1 axis.
Intervention MeSH terms: Contraceptive Agents; NuvaRing; Contraceptives, Oral; Contraceptives, Oral, Combined
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Insulin-like growth factor-1; Combined oral contraceptive; Contraceptive Vaginal Ring; Transdermal Contraceptive

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.
    

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)