drugset / Trial / NCT02367833
Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis
Phase 4
Completed
60 enrolled
Penn State University
Massachusetts General Hospital · collabPurdue University · collab
RandomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2015-01
- Primary completion
- 2017-12
- Completion
- 2018-12
Publications
- Background Grossman D, White K, Hopkins K, Amastae J, Shedlin M, Potter JE. Contraindications to combined oral contraceptives among over-the-counter compared with prescription users. Obstet Gynecol. 2011 Mar;117(3):558-565. doi: 10.1097/AOG.0b013e31820b0244.
- Allaway 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Contraceptive Vaginal Ring | Unknown | 15 ug | Other |
| Subject | Desogestrel | Small molecule | 150 ug | Oral |
| Subject | Etonogestrel | Unknown | 120 ug | Other |
| Subject | Transdermal Contraceptive | Unknown | 20 ug | Other |
| Subject | ethinyl estradiol | Small molecule | 30 ug | Oral |
| Subject | norelgestromin | Unknown | 150 ug | Other |