Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-20 @ 12:46 PM
Study NCT ID:
NCT03737656
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2018-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women
Sponsor:
Grünenthal GmbH
Organization:
Study Overview
Official Title:
Open-label, Randomized, Clinical Trial With Three Groups for the Characterization of Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal women.
Detailed Description:
The objective of the study is to characterize the pharmacokinetics of progesterone in post-menopausal women after the insertion of a vaginal ring containing 2.0 g of progesterone. Progesterone is slowly released from the ring within 90 days (sustained-release). Study participants will use the vaginal ring for a period of 91 days (13 weeks).
Progesterone blood concentrations will be determined during the use of the vaginal ring and after removal of the vaginal ring after a period of use of 13 weeks. In subgroups of participants, progesterone blood concentrations will also be determined after removal of the ring for a period of 2 hours or 4 hours on Day 28 of use. A study participant has completed the study when the final evaluation takes place, which is 7-15 days after removal of the vaginal ring on Day 91.
The safety of the progesterone vaginal ring will be assessed based on the adverse events reported.
Progesterone blood concentrations will be determined during the use of the vaginal ring and after removal of the vaginal ring after a period of use of 13 weeks. In subgroups of participants, progesterone blood concentrations will also be determined after removal of the ring for a period of 2 hours or 4 hours on Day 28 of use. A study participant has completed the study when the final evaluation takes place, which is 7-15 days after removal of the vaginal ring on Day 91.
The safety of the progesterone vaginal ring will be assessed based on the adverse events reported.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: