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NCT03656289
Antepartum Etonogestrel Contraceptive Implant Insertion at Term
Phase 1 trial testing Etonogestrel 68Mg Implant in Contraception. Withdrawn.
15 April 2019
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Start date | 1 January 2019 |
| Primary completion | 15 April 2019 |
| Estimated completion | 15 April 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Etonogestrel 68Mg Implant — full drug profile →
Conditions studied
- Contraception — all drugs for Contraception →
Sponsor
University of Colorado, Denver
Who can join
Adults 18 to 34, female only, with Contraception. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Short-interval pregnancy (SIP) or rapid, repeat pregnancy is defined as a pregnancy within one year of prior delivery. These pregnancies are often unintended and are associated with adverse risks. Low contraceptive initiation during the postpartum period is a contributing factor to SIP. This study will be the first to investigate the initiation of a highly-effective, immediately active contraceptive device during the antepartum period. The antepartum period serves as an ideal time for postpartum contraception counseling, due to patients' active involvement with the healthcare system. The pharmacokinetic analysis proposed in this study will be the first to investigate whether and to what extent ENG hormone crosses the placenta. This data will enrich understanding of the pharmacology of exogenous progestins administered during pregnancy and provide information that can be incorporated into future patient counseling regarding the risks of fetal exposure with exogenous progestin use.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03656289
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Other University of Colorado, Denver trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03656289 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 17 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03656289.
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