Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel

• ClinicalTrials.gov Identifier: NCT00131885
• Recruitment Status: Completed
• First Posted: August 19, 2005
• Results First Posted: June 9, 2010
• Last Update Posted: August 11, 2015
• Sponsor: University of Utah
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Patricia Murphy, University of Utah

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Contraception
• Interventions: Dietary Supplement: Placebo Control (Placebo Herb); Dietary Supplement: St. John's Wort; Drug: Levonorgestrel
• Enrollment: 36

Participant Flow

Recruitment Details	Eligible participants were recruited via local advertising.
Pre-assignment Details	No enrolled participants were excluded

Arm/Group Title	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Arm/Group Description	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	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	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	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
Period Title: Time 1: First Intervention
Started	9	9	9	9
Completed	9	9	9	9
Not Completed	0	0	0	0
Period Title: Time 2: Second Intervention
Started	9	9	9	9
Completed	9	9	9	9
Not Completed	0	0	0	0

Baseline Characteristics

Arm/Group Title		LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG	Total
Arm/Group Description		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	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	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	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 of all reporting groups
Overall Number of Baseline Participants		9	9	9	9	36
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	9 participants	9 participants	9 participants	36 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	9 100.0%	9 100.0%	9 100.0%	9 100.0%	36 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	9 participants	9 participants	9 participants	9 participants	36 participants
		23.1 (3.6)	22.4 (3.1)	23 (3.5)	22.9 (3.4)	22.9 (3.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants	9 participants	9 participants	9 participants	36 participants
	Female	9 100.0%	9 100.0%	9 100.0%	9 100.0%	36 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	9 participants	9 participants	9 participants	9 participants	36 participants
		9	9	9	9	36

Outcome Measures

1. Primary Outcome

Title	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)
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	9	9	9	9
Mean (Standard Deviation); Unit of Measure: ng*hr/mL
AUC 0-24 hours after drug administration Time 1	586.3 (530.6)	379.4 (201.3)	339.4 (201.2)	253.3 (114.4)
AUC 0-24 hours after drug administration Time 2	478.2 (374.0)	317.4 (171.6)	439.4 (320.1)	210.1 (100.4)

2. Primary Outcome

Title	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).
Description	Serum 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.
Time Frame	Progesterone levels drawn at weekly intervals after dosing with levonorgestrel between Days 9 and 12 of the menstrual cycle, at each time point until menses

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	9	9	9	9
Measure Type: Number; Unit of Measure: Participants
Ovulation (Progesterone Levels > 3.0 ng/ml) Time 1	3	1	1	3
Ovulation (Progesterone Levels >3.0 ng/ml) Time 2	3	2	2	2

3. Primary Outcome

Title	Clearance (L/hr) of Levonorgestrel Over 24 Hours for Each Dosage Group and Each Study Session.
Description	Average and standard deviation for Clearance (L/hr) of Levonorgestrel study for each dosage group and each study session.
Time Frame	Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	9	9	9	9
Mean (Standard Deviation); Unit of Measure: L/hr
Clearance (L/hr) Time 1	4.06 (2.60)	4.93 (2.19)	6.39 (4.23)	6.85 (2.51)
Clearance L/hr Time 2	4.64 (2.44)	5.63 (2.08)	7.68 (4.97)	8.92 (4.60)

4. Secondary Outcome

Title	Mean Levels of Follicle-stimulating Hormone Drawn at Weekly Intervals Until Next Menses
Description	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).
Time Frame	Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	9	9	9	9
Mean (Standard Deviation); Unit of Measure: IU/mL
FSH, IU/mL, Time 1, week 0	14.9 (5.7)	14.0 (4.8)	15.8 (8.0)	13.9 (4.3)
FSH, IU/mL, Time 1, week 1	14.5 (5.0)	14.7 (4.8)	13.9 (5.2)	13.6 (4.4)
FSH, IU/mL, Time 1, week 2	13.8 (4.2)	13.4 (4.3)	20.4 (12.0)	15.4 (9.9)
FSH, IU/mL, Time 2, week 0	12.9 (3.5)	13.0 (3.6)	17.5 (10.1)	14.7 (4.1)
FSH, IU/mL, Time 2, week 1	11.8 (3.0)	15.9 (5.0)	17.7 (8.8)	13.8 (4.5)
FSH, IU/mL, Time 2, week 2	11.3 (4.4)	14.1 (4.5)	14.8 (4.7)	16.8 (10.1)

5. Secondary Outcome

Title	Mean Levels of Estradiol-17b (E2) Drawn at Weekly Intervals Until Next Menses
Description	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).
Time Frame	Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	9	9	9	9
Mean (Standard Deviation); Unit of Measure: pg/mL
Estradiol, pg/mL, Time 1, week 0	133.3 (64.3)	137.2 (76.9)	131.1 (75.0)	103.5 (52.2)
Estradiol, pg/mL, Time 1, week 1	142.2 (90.0)	154.7 (117.1)	138.4 (77.7)	290.6 (34.8)
Estradiol, pg/mL,Time 1, week 2	132.4 (103.9)	107.9 (39.3)	132.6 (73.3)	230.4 (34.2)
Estradiol, pg/mL,Time 2, week 0	134.2 (73.9)	102.0 (44.2)	119.3 (77.9)	123.4 (60.2)
Estradiol, pg/mL,Time 2, week 1	210.7 (227.1)	121.6 (57.5)	113.9 (71.1)	118.0 (86.3)
Estradiol, pg/mL,Time 2, week 2	146.3 (80.5)	192.0 (101.2)	102.9 (75.1)	108.7 (47.6)

6. Secondary Outcome

Title	Mean Levels of Luteinizing Hormone, Drawn at Weekly Intervals Until Next Menses
Description	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).
Time Frame	Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	9	9	9	9
Mean (Standard Deviation); Unit of Measure: IU/mL
LH, IU/L, Time 1, week 0	24.7 (10.1)	20.9 (10.4)	26.4 (15.7)	25.3 (15.7)
LH, IU/L, Time 1, week 1	35.1 (16.1)	30.2 (21.8)	24.6 (16.3)	25.3 (15.7)
LH, IU/L, Time 1, week 2	36.2 (20.1)	23.1 (14.7)	25.6 (22.1)	23.2 (18.4)
LH IU/L, Time 2, week 0	33.2 (16.5)	28.4 (14.9)	31.9 (27.5)	46.3 (25.8)
LH, IU/L, Time 2, week 1	30.1 (20.0)	27.5 (17.9)	40.0 (46.5)	28.8 (11.4)
LH, IU/L, Time 2, week 2	29.1 (22.5)	27.7 (19.1)	27.7 (19.1)	39.1 (18.0)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
Arm/Group Description	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	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	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	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
All-Cause Mortality
	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--
Serious Adverse Events
	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/9 (0.00%)	0/9 (0.00%)	0/9 (0.00%)	0/9 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg	LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose	LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/9 (0.00%)	0/9 (0.00%)	0/9 (0.00%)	0/9 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Patricia Murphy, DrPH
• Organization: University of Utah
• Phone: 801-793-5729
• EMail: patricia.murphy@nurs.utah.edu

Publications:

Murphy PA, Kern SE, Stanczyk FZ, Westhoff CL. Interaction of St. John's Wort with oral contraceptives: effects on the pharmacokinetics of norethindrone and ethinyl estradiol, ovarian activity and breakthrough bleeding. Contraception. 2005 Jun;71(6):402-8. doi: 10.1016/j.contraception.2004.11.004.

• Responsible Party: Patricia Murphy, University of Utah
• ClinicalTrials.gov Identifier: NCT00131885
• Other Study ID Numbers: 13430; R21AT002297 ( U.S. NIH Grant/Contract )
• First Submitted: August 17, 2005
• First Posted: August 19, 2005
• Results First Submitted: March 21, 2010
• Results First Posted: June 9, 2010
• Last Update Posted: August 11, 2015