Trial Outcomes & Findings for Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel (NCT NCT00131885)
NCT ID: NCT00131885
Last Updated: 2023-11-13
Results Overview
Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo). Serum samples drawn at 0, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, and 24 hours, following oral administration of a dose of levonorgestrel. Treatment between the two time periods was with St. John's Wort or placebo herb, beginning after the Time 1 (baseline) and continued for 5 weeks until Time 2. Estimates of levonorgestrel clearance were made using a two stage non-compartmental approach to determine individual and group parameters.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
Area Under the Concentration versus Time curve for 0 to 24 hours after drug administration, between Days 9 and 12 of the menstrual cycle, done at Time 1 and at Time 2
Results posted on
2023-11-13
Participant Flow
Eligible participants were recruited via local advertising.
No enrolled participants were excluded
Participant milestones
| Measure |
LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg
Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg
Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose
Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
|---|---|---|---|---|
|
Time 1: First Intervention
STARTED
|
9
|
9
|
9
|
9
|
|
Time 1: First Intervention
COMPLETED
|
9
|
9
|
9
|
9
|
|
Time 1: First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Time 2: Second Intervention
STARTED
|
9
|
9
|
9
|
9
|
|
Time 2: Second Intervention
COMPLETED
|
9
|
9
|
9
|
9
|
|
Time 2: Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel
Baseline characteristics by cohort
| Measure |
LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg
n=9 Participants
Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg
n=9 Participants
Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose
n=9 Participants
Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
n=9 Participants
Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
23.1 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
22.4 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
23 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
22.9 years
STANDARD_DEVIATION 3.4 • n=4 Participants
|
22.9 years
STANDARD_DEVIATION 3.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Area Under the Concentration versus Time curve for 0 to 24 hours after drug administration, between Days 9 and 12 of the menstrual cycle, done at Time 1 and at Time 2Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo). Serum samples drawn at 0, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, and 24 hours, following oral administration of a dose of levonorgestrel. Treatment between the two time periods was with St. John's Wort or placebo herb, beginning after the Time 1 (baseline) and continued for 5 weeks until Time 2. Estimates of levonorgestrel clearance were made using a two stage non-compartmental approach to determine individual and group parameters.
Outcome measures
| Measure |
LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg
n=9 Participants
Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg
n=9 Participants
Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose
n=9 Participants
Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
n=9 Participants
Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve for 0 to 24 Hours After Drug Administration, Done Between Days 9 and 12 of the Menstrual Cycle at Time 1 (Before) and Time 2 (During Treatment With St. John's Wort or Placebo)
AUC 0-24 hours after drug administration Time 1
|
586.3 ng*hr/mL
Standard Deviation 530.6
|
379.4 ng*hr/mL
Standard Deviation 201.3
|
339.4 ng*hr/mL
Standard Deviation 201.2
|
253.3 ng*hr/mL
Standard Deviation 114.4
|
|
Area Under the Concentration Versus Time Curve for 0 to 24 Hours After Drug Administration, Done Between Days 9 and 12 of the Menstrual Cycle at Time 1 (Before) and Time 2 (During Treatment With St. John's Wort or Placebo)
AUC 0-24 hours after drug administration Time 2
|
478.2 ng*hr/mL
Standard Deviation 374.0
|
317.4 ng*hr/mL
Standard Deviation 171.6
|
439.4 ng*hr/mL
Standard Deviation 320.1
|
210.1 ng*hr/mL
Standard Deviation 100.4
|
PRIMARY outcome
Timeframe: Progesterone levels drawn at weekly intervals after dosing with levonorgestrel between Days 9 and 12 of the menstrual cycle, at each time point until mensesSerum progesterone levels were drawn at the time of dosing with levonorgestrel and then at weekly intervals until menses occurred. This was done at Time 1 (baseline), and again at Time 2 (after 5 weeks of dosing with St. John's Wort or placebo). Possible ovulation was defined as a serum progesterone \>3ng/ml within 2 weeks of Days 9-12 of the menstrual cycle.
Outcome measures
| Measure |
LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg
n=9 Participants
Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg
n=9 Participants
Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose
n=9 Participants
Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
n=9 Participants
Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
|---|---|---|---|---|
|
Number of Participants With Progesterone Levels Above 3.0 ng/ml at Time 1 (Baseline) and Time 2 (After Intervention With St John's Wort or Placebo).
Ovulation (Progesterone Levels >3.0 ng/ml) Time 2
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Progesterone Levels Above 3.0 ng/ml at Time 1 (Baseline) and Time 2 (After Intervention With St John's Wort or Placebo).
Ovulation (Progesterone Levels > 3.0 ng/ml) Time 1
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)Average and standard deviation for Clearance (L/hr) of Levonorgestrel study for each dosage group and each study session.
Outcome measures
| Measure |
LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg
n=9 Participants
Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg
n=9 Participants
Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose
n=9 Participants
Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
n=9 Participants
Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
|---|---|---|---|---|
|
Clearance (L/hr) of Levonorgestrel Over 24 Hours for Each Dosage Group and Each Study Session.
Clearance (L/hr) Time 1
|
4.06 L/hr
Standard Deviation 2.60
|
4.93 L/hr
Standard Deviation 2.19
|
6.39 L/hr
Standard Deviation 4.23
|
6.85 L/hr
Standard Deviation 2.51
|
|
Clearance (L/hr) of Levonorgestrel Over 24 Hours for Each Dosage Group and Each Study Session.
Clearance L/hr Time 2
|
4.64 L/hr
Standard Deviation 2.44
|
5.63 L/hr
Standard Deviation 2.08
|
7.68 L/hr
Standard Deviation 4.97
|
8.92 L/hr
Standard Deviation 4.60
|
SECONDARY outcome
Timeframe: Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH). Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo). Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study).
Outcome measures
| Measure |
LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg
n=9 Participants
Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg
n=9 Participants
Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose
n=9 Participants
Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
n=9 Participants
Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
|---|---|---|---|---|
|
Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses
FSH, IU/mL, Time 1, week 1
|
14.5 IU/mL
Standard Deviation 5.0
|
14.7 IU/mL
Standard Deviation 4.8
|
13.9 IU/mL
Standard Deviation 5.2
|
13.6 IU/mL
Standard Deviation 4.4
|
|
Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses
FSH, IU/mL, Time 1, week 2
|
13.8 IU/mL
Standard Deviation 4.2
|
13.4 IU/mL
Standard Deviation 4.3
|
20.4 IU/mL
Standard Deviation 12.0
|
15.4 IU/mL
Standard Deviation 9.9
|
|
Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses
FSH, IU/mL, Time 2, week 0
|
12.9 IU/mL
Standard Deviation 3.5
|
13.0 IU/mL
Standard Deviation 3.6
|
17.5 IU/mL
Standard Deviation 10.1
|
14.7 IU/mL
Standard Deviation 4.1
|
|
Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses
FSH, IU/mL, Time 1, week 0
|
14.9 IU/mL
Standard Deviation 5.7
|
14.0 IU/mL
Standard Deviation 4.8
|
15.8 IU/mL
Standard Deviation 8.0
|
13.9 IU/mL
Standard Deviation 4.3
|
|
Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses
FSH, IU/mL, Time 2, week 1
|
11.8 IU/mL
Standard Deviation 3.0
|
15.9 IU/mL
Standard Deviation 5.0
|
17.7 IU/mL
Standard Deviation 8.8
|
13.8 IU/mL
Standard Deviation 4.5
|
|
Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses
FSH, IU/mL, Time 2, week 2
|
11.3 IU/mL
Standard Deviation 4.4
|
14.1 IU/mL
Standard Deviation 4.5
|
14.8 IU/mL
Standard Deviation 4.7
|
16.8 IU/mL
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH). Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo). Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study).
Outcome measures
| Measure |
LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg
n=9 Participants
Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg
n=9 Participants
Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose
n=9 Participants
Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
n=9 Participants
Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
|---|---|---|---|---|
|
Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses
Estradiol, pg/mL,Time 1, week 2
|
132.4 pg/mL
Standard Deviation 103.9
|
107.9 pg/mL
Standard Deviation 39.3
|
132.6 pg/mL
Standard Deviation 73.3
|
230.4 pg/mL
Standard Deviation 34.2
|
|
Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses
Estradiol, pg/mL,Time 2, week 0
|
134.2 pg/mL
Standard Deviation 73.9
|
102.0 pg/mL
Standard Deviation 44.2
|
119.3 pg/mL
Standard Deviation 77.9
|
123.4 pg/mL
Standard Deviation 60.2
|
|
Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses
Estradiol, pg/mL,Time 2, week 2
|
146.3 pg/mL
Standard Deviation 80.5
|
192.0 pg/mL
Standard Deviation 101.2
|
102.9 pg/mL
Standard Deviation 75.1
|
108.7 pg/mL
Standard Deviation 47.6
|
|
Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses
Estradiol, pg/mL, Time 1, week 0
|
133.3 pg/mL
Standard Deviation 64.3
|
137.2 pg/mL
Standard Deviation 76.9
|
131.1 pg/mL
Standard Deviation 75.0
|
103.5 pg/mL
Standard Deviation 52.2
|
|
Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses
Estradiol, pg/mL, Time 1, week 1
|
142.2 pg/mL
Standard Deviation 90.0
|
154.7 pg/mL
Standard Deviation 117.1
|
138.4 pg/mL
Standard Deviation 77.7
|
290.6 pg/mL
Standard Deviation 34.8
|
|
Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses
Estradiol, pg/mL,Time 2, week 1
|
210.7 pg/mL
Standard Deviation 227.1
|
121.6 pg/mL
Standard Deviation 57.5
|
113.9 pg/mL
Standard Deviation 71.1
|
118.0 pg/mL
Standard Deviation 86.3
|
SECONDARY outcome
Timeframe: Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)Descriptive reporting of secondary outcomes of reproductive hormone levels (including FSH, E2, LH). Pharmacokinetic studies were done between Days 9-12 of the menstrual cycle at Time 1 (baseline, before any treatment with herb or placebo), and at Time 2 (intervention, after treatment with herb or placebo). Weekly means are reported for both time periods at week 0 (day of pharmacokinetic study), week 1 (one week after pharmacokinetic study) and week 2 (2 weeks after pharmacokinetic study).
Outcome measures
| Measure |
LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg
n=9 Participants
Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg
n=9 Participants
Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose
n=9 Participants
Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John's Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
|
LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
n=9 Participants
Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John's Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
|
|---|---|---|---|---|
|
Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses
LH, IU/L, Time 1, week 2
|
36.2 IU/mL
Standard Deviation 20.1
|
23.1 IU/mL
Standard Deviation 14.7
|
25.6 IU/mL
Standard Deviation 22.1
|
23.2 IU/mL
Standard Deviation 18.4
|
|
Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses
LH, IU/L, Time 2, week 1
|
30.1 IU/mL
Standard Deviation 20.0
|
27.5 IU/mL
Standard Deviation 17.9
|
40.0 IU/mL
Standard Deviation 46.5
|
28.8 IU/mL
Standard Deviation 11.4
|
|
Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses
LH, IU/L, Time 1, week 0
|
24.7 IU/mL
Standard Deviation 10.1
|
20.9 IU/mL
Standard Deviation 10.4
|
26.4 IU/mL
Standard Deviation 15.7
|
25.3 IU/mL
Standard Deviation 15.7
|
|
Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses
LH, IU/L, Time 1, week 1
|
35.1 IU/mL
Standard Deviation 16.1
|
30.2 IU/mL
Standard Deviation 21.8
|
24.6 IU/mL
Standard Deviation 16.3
|
25.3 IU/mL
Standard Deviation 15.7
|
|
Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses
LH IU/L, Time 2, week 0
|
33.2 IU/mL
Standard Deviation 16.5
|
28.4 IU/mL
Standard Deviation 14.9
|
31.9 IU/mL
Standard Deviation 27.5
|
46.3 IU/mL
Standard Deviation 25.8
|
|
Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses
LH, IU/L, Time 2, week 2
|
29.1 IU/mL
Standard Deviation 22.5
|
27.7 IU/mL
Standard Deviation 19.1
|
27.7 IU/mL
Standard Deviation 19.1
|
39.1 IU/mL
Standard Deviation 18.0
|
Adverse Events
LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place