Phase 4
Completed N=26
Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis
Bone; Disorder, Development and Growth
Source: ClinicalTrials.gov NCT02367833 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Changes in Insulin-like Growth Factor-1 (IGF-1), IGF Binding Proteins (IGFBP-1, IGFBP-3), and Acid Labile Subunit (ALS) — 220.6; 228.7; 197.1; 221.4 ng/mL
◆ Published Evidence
Emerging
16citations · ~3 / year
Are the Effects of Oral and Vaginal Contraceptives on Bone Formation in Young Women Mediated via the Growth Hormone-IGF-I Axis?
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.
Linked Publications
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Are the Effects of Oral and Vaginal Contraceptives on Bone Formation in Young Women Mediated via the Growth Hormone-IGF-I Axis?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Insulin-like Growth Factor-1 (IGF-1), IGF Binding Proteins (IGFBP-1, IGFBP-3), and Acid Labile Subunit (ALS) |
220.6; 228.7; 197.1; 221.4; 185.9; 175.2 | — |
| SECONDARY Changes in Bone Turnover Markers |
— | — |
| SECONDARY Changes in GH-stimulated IGF-1 Secretion |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02367833) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.