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NCT07222228
A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception
Phase 2 trial testing Levonorgestrel butanoate in Healthy Women in 165 participants. Not yet recruiting.
31 December 2028
Quick facts
| Lead sponsor | Premier Research |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 165 |
| Start date | 1 April 2026 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 March 2029 |
Drugs / interventions tested
- Levonorgestrel butanoate — full drug profile →
Conditions studied
- Healthy Women — all drugs for Healthy Women →
- Female Contraception — all drugs for Female Contraception →
Sponsor
Premier Research — full company profile →
Who can join
Adults 18 to 35, female only, with Healthy Women or Female Contraception. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, open-label, Phase 2b study to evaluate the efficacy and safety of 2 LB SQ injections administered at a 4-month (approximately 17 weeks) interval for female contraception.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07222228
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy Women
Currently open trials in the same condition.
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- NCT07439458 — Tumour Cell Response to Acute Aerobic Exercise in Breast Cancer Survivors: Modulatory Effects of Exercise Type and Inten · NA · recruiting
- NCT04143659 — A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception · Phase 1 · active not recruiting
Other Premier Research trials
Trials by the same sponsor.
- NCT04143659 — A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception · Phase 1 · active not recruiting
- NCT03452111 — Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception · Phase 2 · completed
- NCT03455075 — Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men · Phase 2 · completed
- NCT03432416 — Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring · Phase 2 · completed
- NCT03298373 — 28-Day Repeat-Dose, Dose Escalation Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men · Phase 1 · unknown
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 NCT07222228 (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 Premier Research
- Last refreshed: 29 October 2025
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/NCT07222228.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing