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NCT02170038
Open Label, One-way Crossover Study to Assess the in Vivo Formation of Ethinylestradiol Following Single Intramuscular Administration of 200 mg Norethisterone Enantate Compared to Ethinylestradiol Pharmacokinetics After Multiple Doses of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Women
Phase 1 trial testing Microgynon in Pharmacokinetics in 16 participants. Completed in 1 March 2015.
1 December 2014
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 16 |
| Start date | 1 June 2014 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 March 2015 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Microgynon — full drug profile →
- Noristerat(BAY86-6308) — full drug profile →
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 45, female only, with Pharmacokinetics. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss
Time frame: At different time points on day 21 -
Area under the concentration-time curve of ethinylestradiol at steady state after multiple administrations of Microgynon {AUC(0-24)}ss
Time frame: At different time points on day 21 -
Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)
Time frame: At different time points upto 8 weeks -
Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)
Time frame: At different time points up to 8 weeks -
Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)
Time frame: At different time points up to 8 weeks -
Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)
Time frame: At different time points up to 8 weeks
Sponsor's own description
The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore concentrations of ethinylestradiol will be measured from blood samples after administration of a single intramuscular dose of norethisterone. In a comparison arm concentrations of ethinylestradiol will be measured from blood samples after administration of a pill containing ethinylestradiol itself.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02170038
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Microgynon
Trials testing the same drug.
- NCT06354257 — A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GS · Phase 1 · completed
- NCT03675581 — A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Ass · Phase 1 · completed
- NCT03210246 — Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Or · Phase 1 · completed
- NCT02751385 — Investigation of the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestre · Phase 1 · terminated
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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 NCT02170038 (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 Bayer
- Last refreshed: 17 February 2016
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/NCT02170038.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing