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

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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:
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
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
Hide 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
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
Hide 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
Hide 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
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Time Frame Time Frame: Time 1 (pre-intervention baseline) and Time 2 (following a 6 week intervention)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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
Responsible Party: Patricia Murphy, University of Utah
ClinicalTrials.gov Identifier: NCT00131885     History of Changes
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