CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Combined Oral Contraceptive +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02367833
NCT02367833Phase 4Completed
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Primary Mechanisms Underlying the Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis and Bone Metabolism in Young Women

Penn State University·interventional·Posted Feb 20, 2015·Updated Mar 9, 2020

In Brief

A Phase 4 clinical trial evaluating Combined Oral Contraceptive, Transdermal Contraceptive, and 1 other intervention for Bone; Disorder, Development and Growth. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone; Disorder, Development and Growth
CountriesUnited States
CollaboratorsMassachusetts General Hospital, Purdue University

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 20, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2017
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.4 years ago

Interventions

Combined Oral Contraceptivedrug

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.

Transdermal Contraceptivedrug

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.

Contraceptive Vaginal Ringdrug

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.