Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT02367833Other idSTUDY00000053

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures IGF-1 (mecasermin), does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Phase 4
Enrollment: 60 participants (actual)
Sponsor: Penn State University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jan 2015
Primary completion: Dec 2017
Completion: Dec 2018
First posted: 20 Feb 2015 (estimated)
Last update posted: 9 Mar 2020
Conditions: Bone; Disorder, Development and Growth

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20152016201720182019

Ph 4
Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis
NCT02367833
Jan 2015 to Dec 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Combined Oral ContraceptiveDrug
Transdermal ContraceptiveDrug
Contraceptive Vaginal RingDrug

Arms4

Experimental
Combined Oral Contraceptives (COC)
Apri (or generic equivalent - Reclipsen) (30µg/d EE, 150 µg/d desogestrel) is a monophasic dosing regimen of 21 active and 7 placebo pills. On Day 1 of the Intervention, participants in the COC group will begin taking the COC pill. Each participant in this group will ingest active pills from the first pack each day for the first 21 days. Pills ingested on days 22 through 28 are placebo pills. A second pill pack will begin on day 29 and pills with active ingredients will be ingested from the second pack each day for days 29-49. On day 50, the participants will immediately begin a 3rd pill pack, if the post-study testing is still occurring, and will ingest a pill with active ingredients from the third pack for days 50-56 (or for as long as the post-study testing is occurring).
Experimental
Transdermal Contraceptive (TDC)
Participants in the TDC group will apply a 20 cm2 patch (Xulane: 20µg/d EE,150µg/d norelgestromin) to the abdomen, upper arm or buttock. The patch will be changed once weekly on the same day each week for weeks 1-3 (days 1-21, removed on day 22) and weeks 5-8 (days 29-56). Week 4 (days 22-28) will be a patch-free week. As soon as the post-study testing is complete, subjects will remove the patch.
Experimental
Contraceptive Vaginal Ring (CVR)
Participants in the CVR group (NuvaRing - 15µg/d EE/120µg/d etonogestrel) will insert a vaginal ring into the vagina on Day 1 of the intervention. The vaginal ring will be removed and discarded after 3 weeks of continuous use (days 1-21 of continuous use and removed on day 22). There will be one week (days 22-28) that will be ring-free. A new ring will be inserted for days 29-49. On day 50, the second ring will be removed, and a third ring will be immediately inserted into the vagina (if the post-study testing is still occurring). The third ring will remain in the vagina for the last week of the post-study period (days 50-56). As soon as the post-study testing is complete, subjects will remove the ring.
No intervention
Control Group
The Control group will complete all procedures with the exception of contraceptive therapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

Changes in Insulin-like Growth Factor-1 (IGF-1), IGF Binding Proteins (IGFBP-1, IGFBP-3), and Acid Labile Subunit (ALS)
Time frame · Baseline and post-49 days of contraceptive therapy
Registry description
Changes in serially-sampled fasting serum concentrations of insulin-like growth factor-1 (IGF-1) before and after 49 days of contraceptive therapy. Data were only collected for IGF-1 levels, no assays were performed for IGFBP-1, IGFBP-3, and acid labile subunit (ALS) and no raw data were collected due to insufficient funds.

Secondary outcomes(2)

Changes in Bone Turnover Markers
Time frame · Baseline and post-49 days of contraceptive therapy
Registry description
Changes in serially-sampled fasting serum concentrations of markers of bone formation (osteocalcin, P1NP) and bone resorption (NTx, and CTx) before and after contraceptive therapy.
Changes in GH-stimulated IGF-1 Secretion
Time frame · 49 days of contraceptive therapy
Registry description
Changes in IGF-1, IGFBP-1, IGFBP-3,and ALS in response to exogenously administered GH before and after contraceptive therapy.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and post-49 days of contraceptive therapy

Changes in Insulin-like Growth Factor-1 (IGF-1), IGF Binding Proteins (IGFBP-1, IGFBP-3), and Acid Labile Subunit (ALS)

Group	Value (ng/mL)	Spread
Control Group	220.6	14.8
Combined Oral Contraceptives (COC)	228.7	13.6
Contraceptive Vaginal Ring (CVR)	197.1	15.2

Secondary and other outcome results(2)

Secondary outcome· Baseline and post-49 days of contraceptive therapy

Changes in Bone Turnover Markers

Group	Value
Control Group	not posted
Combined Oral Contraceptives (COC)	not posted
Contraceptive Vaginal Ring (CVR)	not posted

Secondary outcome· 49 days of contraceptive therapy

Changes in GH-stimulated IGF-1 Secretion

Group	Value
Control Group	not posted
Combined Oral Contraceptives (COC)	not posted
Contraceptive Vaginal Ring (CVR)	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Control GroupThe Control group will complete all procedures with the exception of contraceptive therapy.	0 / 8	0 / 8	0 / 8
Combined Oral Contraceptives (COC)Apri (or generic equivalent - Reclipsen) (30µg/d EE, 150 µg/d desogestrel) is a monophasic dosing regimen of 21 active and 7 placebo pills. On Day 1 of the Intervention, participants in the COC group will begin taking the COC pill. Each participant in this group will ingest active pills from the first pack each day for the first 21 days. Pills ingested on days 22 through 28 are placebo pills. A second pill pack will begin on day 29 and pills with active ingredients will be ingested from the second pack each day for days 29-49. On day 50, the participants will immediately begin a 3rd pill pack, if the post-study testing is still occurring, and will ingest a pill with active ingredients from the third pack for days 50-56 (or for as long as the post-study testing is occurring).	0 / 9	0 / 9	0 / 9
Contraceptive Vaginal Ring (CVR)Participants in the CVR group (NuvaRing - 15µg/d EE/120µg/d etonogestrel) will insert a vaginal ring into the vagina on Day 1 of the intervention. The vaginal ring will be removed and discarded after 3 weeks of continuous use (days 1-21 of continuous use and removed on day 22). There will be one week (days 22-28) that will be ring-free. A new ring will be inserted for days 29-49. On day 50, the second ring will be removed, and a third ring will be immediately inserted into the vagina (if the post-study testing is still occurring). The third ring will remain in the vagina for the last week of the post-study period (days 50-56). As soon as the post-study testing is complete, subjects will remove the ring.	0 / 9	0 / 9	0 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedAllaway HCM, Misra M, Southmayd EA, Stone MS, Weaver CM, Petkus DL, De Souza MJ. Are the Effects of Oral and Vaginal Contraceptives on Bone Formation in Young Women Mediated via the Growth Hormone-IGF-I Axis? Front Endocrinol (Lausanne). 2020 Jun 16;11:334. doi: 10.3389/fendo.2020.00334. eCollection 2020. PMID 32612574

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 30 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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)

PepBank is a research reference. Talk to a doctor before you use any peptide.