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NCT03737656
Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women
Phase 1 trial testing Progesterone vaginal ring in Pharmacokinetics in 106 participants. Completed in 9 May 2019.
3 May 2019
Quick facts
| Lead sponsor | Grünenthal GmbH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 106 |
| Start date | 1 November 2018 |
| Primary completion | 3 May 2019 |
| Estimated completion | 9 May 2019 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Progesterone vaginal ring — full drug profile →
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Grünenthal GmbH — full company profile →
Who can join
Adults 40 to 65, female only, with Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal women.
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 NCT03737656
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Progesterone vaginal ring
Trials testing the same drug.
- NCT03565211 — Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures · Phase 3 · completed
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Other Grünenthal GmbH trials
Trials by the same sponsor.
- NCT07479745 — Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 · Phase 1 · recruiting
- NCT07289776 — A First-in-human Trial of GRT7041 in Healthy Participants · Phase 1 · recruiting
- NCT07317063 — A Trial to Investigate Safety and Pharmacokinetics of GRT6019, Including Food Effect, in Healthy Male Participants · Phase 1 · completed
- NCT05449132 — Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the · Phase 3 · completed
- NCT05377489 — Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis · 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 NCT03737656 (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 Grünenthal GmbH
- Last refreshed: 5 June 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/NCT03737656.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing