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

Completed · Phase 4

Conditions studied: Bone; Disorder, Development and Growth

In brief

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.

Key facts

Study ID

NCT02367833

Run by

Penn State University

People needed

60

Starts

2015-01-01

Expected to finish

2018-12-01

Last updated by the study team

2020-03-09

Who can join

Age: 18 and older, up to 30. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female
• Age 18-30 yrs
• BMI 18-29 kg/m2
• Non-smoking
• Not using hormonal contraceptives for at least 6 months prior
• Not currently pregnant nor intending to become pregnant in the next 6 months
• Not lactating
• No apparent metabolic, endocrine, musculoskeletal, or severe psychiatric disease
• Willing to adhere to maintenance of current exercise training and diet and remain weight stable (±2 kg) during study
• Variable physical activity acceptable, but mode must be primarily weight bearing
• At least 9 menses in past 12 months
• Willing to quit taking any current nutritional supplements and take Calcium and Vitamin D supplements for the duration of the study.
• If 21 or older, a normal Pap smear must be confirmed.

You may not qualify if…

• Non-weight bearing exercise as primary mode of physical activity
• Known or suspected metabolic or endocrine disease
• Pregnant
• Currently consuming large amounts of soy products
• Regular consumption of grapefruit juice
• Current clinical eating disorder or other axis 1 psychiatric or bipolar disorders
• Oral or hormonal contraceptive use in the last 6 months
• Currently amenorrheic
• Hyperparathyroidism
• Liver or renal disease
• Evidence of malabsorption or skeletal disorder
• Thyroid abnormalities (controlled hypothyroidism acceptable)
• Chronic use of non-steroidal anti-inflammatory drugs (NSAIDS)
• Taking medications known to have interactions with contraceptive therapy
• Division I Athlete, on or off season
• Other Exclusion Criteria proposed by the World Health Organization COC Contraindications (Grossman, 2011)

Where it is running

• Women's Health and Exercise Laboratories, The Pennsylvania State University — University Park, Pennsylvania, United States

Full record on ClinicalTrials.gov

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