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NCT03512860
Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study
Phase 1 trial testing E4/DRSP in Contraception in 24 participants. Completed in 8 October 2018.
8 October 2018
Quick facts
| Lead sponsor | Estetra |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 24 |
| Start date | 12 April 2018 |
| Primary completion | 8 October 2018 |
| Estimated completion | 8 October 2018 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
Conditions studied
- Contraception — all drugs for Contraception →
Sponsor
Estetra — full company profile →
Who can join
Adults 18 to 45, female only, with Contraception. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7 inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4)
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 NCT03512860
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Contraception
Currently open trials in the same condition.
- NCT07365904 — Investigating Ovulation Inhibition for Use as a Contraceptive · Phase 2 · recruiting
- NCT07437495 — Women's Knowledge of Contraception During the Postpartum Period · active not recruiting
- NCT06823037 — Hormonal Contraception Access Through Pharmacist Prescribing Implementation · NA · recruiting
- NCT07326007 — Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women W · NA · recruiting
- NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years · NA · recruiting
Other Estetra trials
Trials by the same sponsor.
- NCT06308614 — Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women · Phase 2 · completed
- NCT04819906 — Effect of Estetrol Monohydrate (E4) on QTc Interval · Phase 1 · completed
- NCT04792385 — Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescent · Phase 3 · completed
- NCT04209543 — Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I) · Phase 3 · completed
- NCT04090957 — Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II) · Phase 3 · completed
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 NCT03512860 (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 Estetra
- Last refreshed: 14 December 2018
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/NCT03512860.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing