Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131885
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2005-08-17
Brief Title:
Effects of St Johns Wort on the Oral Contraceptive Hormone Levonorgestrel
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Effects of St Johns Wort on Levonorgestrel
Status:
COMPLETED
Status Verified Date:
2023-11
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 study will determine the effects of St Johns wort a common herbal remedy on metabolism of the female contraceptive hormone levonorgestrel
Detailed Description:
In the last decade St Johns wort has become one of the most commonly used botanicals Levonorgestrel is a form of progesterone a female hormone involved in conception It can be given as both a pill and an injection and is used for contraception and for the treatment of endometriosis However evidence suggests that St Johns wort may reduce the effectiveness of the contraceptive hormone levonorgestrel This study will determine whether interactions between St Johns wort and levonorgestrel reduce the effectiveness of the hormone This study will also determine whether a higher dose of levonorgestrel will override the effects of St Johns wort
All participants will receive a single dose of levonorgestrel between Days 9 and 12 of their first menstrual cycle after entering this study Blood and urine collection will occur immediately after the levonorgestrel is given and every week until participants next menstrual cycle to determine the levels of reproductive hormones in participants bodies
At the beginning of participants next menstrual cycle they will be randomly assigned to one of four groups and receive either St Johns wort or placebo for 6 weeks Group 1 will receive a placebo Groups 2 and 3 will receive a standard dose of St Johns wort 900 mg per day and Group 4 will receive an increased dose of St Johns wort 1500 mg per day After 6 weeks Groups 1 2 and 4 will receive 150 mcg levonorgestrel and Group 3 will receive 225 mcg levonorgestrel Blood and urine collection will occur immediately after levonorgestrel is given and every week until participants next menstrual cycle
All participants will receive a single dose of levonorgestrel between Days 9 and 12 of their first menstrual cycle after entering this study Blood and urine collection will occur immediately after the levonorgestrel is given and every week until participants next menstrual cycle to determine the levels of reproductive hormones in participants bodies
At the beginning of participants next menstrual cycle they will be randomly assigned to one of four groups and receive either St Johns wort or placebo for 6 weeks Group 1 will receive a placebo Groups 2 and 3 will receive a standard dose of St Johns wort 900 mg per day and Group 4 will receive an increased dose of St Johns wort 1500 mg per day After 6 weeks Groups 1 2 and 4 will receive 150 mcg levonorgestrel and Group 3 will receive 225 mcg levonorgestrel Blood and urine collection will occur immediately after levonorgestrel is given and every week until participants next menstrual cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT002297 | NIH | None | httpsreporternihgovquickSearchR21AT002297 |