Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00179517
• Collaborator: AstraZeneca (Industry)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 82
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if treatment using a medication (anastrozole/Arimidex), which lowers estrogen levels in the blood is better than placebo, a tablet that does not contain any active medication, when combined with testosterone replacement to treat reproductive and sexual dysfunction in men with epilepsy. Anastrozole, the medication that is currently under study, does not, at this time, have FDA approval for use for this indication.

Condition or Disease	Intervention/Treatment	Phase
Seizure Disorder; Hypogonadism; Erectile Dysfunction	Drug: Anastrozole 1mg; Drug: Placebo Oral Tablet	Phase 2

Detailed Description

This is a three-month study where baseline information is collected at the first visit and then each patient is started on treatment with testosterone supplementation and either anastrozole or placebo. Lab tests, seizure frequency, sexual function and mood will be monitored on a monthly basis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Comparison of Anastrozole and Testosterone Versus Placebo and Testosterone Treatment of Reproductive and Sexual Dysfunction in Men With Epilepsy and Hypogonadism
• Study Start Date: Jun 1, 2001
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: depotestosterone plus anastrozole (T-A) Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes an oral tablet of anastrozole 1 mg daily for the duration of the study. This group is referred to as the depotestosterone plus anastrozole (T-A) group.	Drug: Anastrozole 1mg; Other Names: Arimidex
Placebo Comparator: depotestosterone plus placebo (T-P) Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo oral tablet daily for the duration of the study. This group is referred to as the depotestosterone plus placebo (T-P) group.	Drug: Placebo Oral Tablet

Outcome Measures

Primary Outcome Measures

1. Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. [3 month average]

   S-Scores and Reynolds Questionnaire scores were assessed at baseline and once a month over three months. The average change in score for each questionnaire over the 3 month study was reported. The S-Scores questionnaire measured sexual function and consisted of four questions with five possible answers. The total scale range was 0-20, with higher scores were considered better. S-Scores that were greater than or equal to 16/20 were considered normalized S-Scores. Reynolds Questionnaire is a 21 item survey that monitors sexual interest, activity, satisfaction, and function. The scale for the Reynolds questionnaire for sexual interest was from 0-12, with higher scores being better. The scale for sexual activity was 0-41 with higher scores being better. The sexual satisfaction scale was from 0-21 with higher scores being better. The scale for sexual function was from 0 to -12 with lower scores being better.

Secondary Outcome Measures

1. The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo [Assessed for 3 months]

   The proportion of men who achieve normalization of sexual scores (scores greater than or equal to 16/20) on anastrozole (T-A) and those on placebo (T-P) are reported. Both Men who achieve normalization of sexual scores and those who did not achieve normalization of sexual scores were reported for anastrozole (T-A) treatment group and the placebo treatment group. Sexual scores were gathered once per month for three months with the average of the three months reported.

2. Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P). [Assessed for 3 months]

   Bioavailable testosterone levels were measured at baseline and once a month over the three month study. The average change in bioactive testosterone levels from baseline to the end of the three month study was reported.

3. Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P). [Assessed for 3 months]

   Estradiol levels were measured once a month over the three month study in subjects taking anastrozole (T-A) and in subjects taking placebo (T-P). The average change in estradiol levels was reported.

4. The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo. [Assessed for 3 months]

   Bioavailable testosterone and estradiol levels were measured once a month over the three month study in subjects taking anastrozole and subjects taking placebo. The bioavailable testosterone and estradiol levels for the three months were averaged for each subject. The ratio between the average bioavailable testosterone level and average estradiol levels were reported.

5. Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P). [Assessed for 3 months]

   Bioavailable Testosterone and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The bioactive testosterone and luteinizing hormone levels were averaged for the three months. The ratio between the average bioactive testosterone level and average luteinizing hormone levels were reported.

6. Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P). [Assessed for 3 months]

   Estradiol and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The estradiol and luteinizing hormone levels were averaged for the three months. The ratio between the average estradiol levels and average luteinizing hormone levels were reported.

7. Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P). [Assessed for 3 months]

   The average change in number of seizures over the 3 month study for the depotestosterone plus anastrozole (T-A) and depotestosterone plus placebo (T-P) were reported.

8. Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P). [Assessed for 3 months]

   Changes in energy, mood and anxiety scores were measured using The Beck Depression Inventory II and the POMS questionnaire. The Beck Depression Inventory II questionnaire consisted of 21 questions, each with answers ranging from 0-3. The answers for each question were summed. The scale ranged from 0-63 with higher scores meaning a higher depression score (worse score). The POMS questionnaire had a total of 65 questions that measured tension, depression, anger, vigor, fatigue and confusion. The total POMS score ranged from 0-200, with lower scores being better. The POMS tension score ranged from 0-36 with lower scores being better. The POMS depression score ranged from 0-60 with lower scores being better. The POMS anger score ranged from 0-48, lower scores being better. The POMS vigor score ranged from 0-32, lower scores being better. The POMS fatigue score ranged from 0-28, lower scores being better. The POMS confusion score ranged from 0-28 with lower scores being better.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject must be a male between the ages of 18 and 50 years.

• Subject must have localization-related epilepsy with complex partial and/or secondary generalized seizures.

• Subject will meet criteria for hypogonadism (abnormally low bioactive testosterone levels and abnormally low scores on questionnaires of reproductive and sexual function).

• Subject will have had a normal urogenital and rectal/prostate exam during the year prior to entry.

• Subject will have had documentation of therapeutic range serum AED levels, a normal CBC, and hepatic enzyme (ALT,AST, alkaline phosphatase) levels that are less than twofold elevated during the 6 months prior to entry.

Exclusion Criteria:

• Subject that has taken hormones, major tranquilizers or antidepressants in the three months prior to entry.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center
• AstraZeneca

Investigators

• Principal Investigator: Andrew Herzog, M.D., M.Sc., Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Herzog AG, Farina EL, Drislane FW, Schomer DL, Smithson SD, Fowler KM, Dworetzky BA, Bromfield EB. A comparison of anastrozole and testosterone versus placebo and testosterone for treatment of sexual dysfunction in men with epilepsy and hypogonadism. Epilepsy Behav. 2010 Feb;17(2):264-71. doi: 10.1016/j.yebeh.2009.12.003. Epub 2010 Jan 21.

• Responsible Party: Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00179517
• Other Study ID Numbers: 2001P000149; IRUSANAS0004
• First Posted: Sep 16, 2005
• Last Update Posted: Jul 17, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center: Seizure; Epilepsy; Testosterone; Hormone; Sexual Dysfunction; Hypogonadism; Men
• Additional relevant MeSH terms: Epilepsy; Seizures; Erectile Dysfunction; Hypogonadism; Anastrozole

Study Results

Participant Flow

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Period Title: Overall Study
STARTED	20	20
COMPLETED	18	19
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)	Total
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet	Total of all reporting groups
Overall Participants	18	19	37
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.3 (7.5)	42.7 (7.2)	43.0 (7.3)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	18 100%	19 100%	37 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	18 100%	19 100%	37 100%
Participants with Epilepsy (Count of Participants)
Count of Participants [Participants]	18 100%	19 100%	37 100%

Outcome Measures

1. Primary Outcome

Title	Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.
Description	S-Scores and Reynolds Questionnaire scores were assessed at baseline and once a month over three months. The average change in score for each questionnaire over the 3 month study was reported. The S-Scores questionnaire measured sexual function and consisted of four questions with five possible answers. The total scale range was 0-20, with higher scores were considered better. S-Scores that were greater than or equal to 16/20 were considered normalized S-Scores. Reynolds Questionnaire is a 21 item survey that monitors sexual interest, activity, satisfaction, and function. The scale for the Reynolds questionnaire for sexual interest was from 0-12, with higher scores being better. The scale for sexual activity was 0-41 with higher scores being better. The sexual satisfaction scale was from 0-21 with higher scores being better. The scale for sexual function was from 0 to -12 with lower scores being better.
Time Frame	3 month average

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Measure Participants	18	19
Change in S-Score	3.7 (1.6)	2.5 (2.2)
Reynolds Questionnaire Change in R-Interest	2.4 (2.1)	1.5 (2.6)
Reynolds Questionnaire Change in R-Activity	11.1 (25.7)	4.7 (7.9)
Reynolds Questionnaire Change in R-Satisfaction	2.4 (3.7)	2.1 (3.3)
Reynolds Questionnaire Change in R-Function	-1.7 (7.4)	-1.3 (4.1)

2. Secondary Outcome

Title	The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo
Description	The proportion of men who achieve normalization of sexual scores (scores greater than or equal to 16/20) on anastrozole (T-A) and those on placebo (T-P) are reported. Both Men who achieve normalization of sexual scores and those who did not achieve normalization of sexual scores were reported for anastrozole (T-A) treatment group and the placebo treatment group. Sexual scores were gathered once per month for three months with the average of the three months reported.
Time Frame	Assessed for 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Measure Participants	18	19
Normalization of S-Score	13 72.2%	9 47.4%
No Normalization of S-Score	5 27.8%	10 52.6%

3. Secondary Outcome

Title	Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
Description	Bioavailable testosterone levels were measured at baseline and once a month over the three month study. The average change in bioactive testosterone levels from baseline to the end of the three month study was reported.
Time Frame	Assessed for 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Measure Participants	18	19
Mean (Standard Deviation) [ng/dl]	150.9 (144.0)	161.7 (123.1)

4. Secondary Outcome

Title	Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
Description	Estradiol levels were measured once a month over the three month study in subjects taking anastrozole (T-A) and in subjects taking placebo (T-P). The average change in estradiol levels was reported.
Time Frame	Assessed for 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Measure Participants	18	19
Mean (Standard Deviation) [pg/mL]	-14.6 (17.3)	8.6 (19.6)

5. Secondary Outcome

Title	The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo.
Description	Bioavailable testosterone and estradiol levels were measured once a month over the three month study in subjects taking anastrozole and subjects taking placebo. The bioavailable testosterone and estradiol levels for the three months were averaged for each subject. The ratio between the average bioavailable testosterone level and average estradiol levels were reported.
Time Frame	Assessed for 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Measure Participants	18	19
Mean (Standard Deviation) [Ratio]	145.47 (143.00)	12.78 (10.21)

6. Secondary Outcome

Title	Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
Description	Bioavailable Testosterone and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The bioactive testosterone and luteinizing hormone levels were averaged for the three months. The ratio between the average bioactive testosterone level and average luteinizing hormone levels were reported.
Time Frame	Assessed for 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Measure Participants	18	19
Mean (Standard Deviation) [Ratio]	450.24 (193.17)	482.65 (346.10)

7. Secondary Outcome

Title	Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
Description	Estradiol and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The estradiol and luteinizing hormone levels were averaged for the three months. The ratio between the average estradiol levels and average luteinizing hormone levels were reported.
Time Frame	Assessed for 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Measure Participants	18	19
Mean (Standard Deviation) [Ratio]	9.31 (8.84)	53.80 (47.25)

8. Secondary Outcome

Title	Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P).
Description	The average change in number of seizures over the 3 month study for the depotestosterone plus anastrozole (T-A) and depotestosterone plus placebo (T-P) were reported.
Time Frame	Assessed for 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Measure Participants	18	19
Mean (Standard Deviation) [number of seizures]	-2.0 (1.2)	-2.9 (2.9)

9. Secondary Outcome

Title	Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Description	Changes in energy, mood and anxiety scores were measured using The Beck Depression Inventory II and the POMS questionnaire. The Beck Depression Inventory II questionnaire consisted of 21 questions, each with answers ranging from 0-3. The answers for each question were summed. The scale ranged from 0-63 with higher scores meaning a higher depression score (worse score). The POMS questionnaire had a total of 65 questions that measured tension, depression, anger, vigor, fatigue and confusion. The total POMS score ranged from 0-200, with lower scores being better. The POMS tension score ranged from 0-36 with lower scores being better. The POMS depression score ranged from 0-60 with lower scores being better. The POMS anger score ranged from 0-48, lower scores being better. The POMS vigor score ranged from 0-32, lower scores being better. The POMS fatigue score ranged from 0-28, lower scores being better. The POMS confusion score ranged from 0-28 with lower scores being better.
Time Frame	Assessed for 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)	Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
Measure Participants	18	19
Change in Depression (Beck Depression Inventory II	-5.3 (7.6)	-6.4 (9.4)
Change in Vigor	4.6 (5.9)	4.8 (7.6)
Change in Fatigue	-6.0 (5.4)	-4.5 (8.1)
Change in Depression (POMS-D)	-5.6 (0.6)	-6.7 (11.5)
Change in Anxiety (POMS-T)	-3.0 (5.8)	-4.2 (7.4)
Change in Anger (POMS A)	-2.4 (8.7)	-2.6 (8.9)
Change in Confusion (POMS-C)	-2.7 (4.1)	-2.7 (5.7)

Adverse Events

Arm/Group Title	Depotestosterone Plus Anastrozole (T-A)		Depotestosterone Plus Placebo (T-P)
Arm/Group Description	Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study. Anastrozole 1mg		Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study. Placebo Oral Tablet
All Cause Mortality
	Depotestosterone Plus Anastrozole (T-A)		Depotestosterone Plus Placebo (T-P)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/19 (0%)
Serious Adverse Events
	Depotestosterone Plus Anastrozole (T-A)		Depotestosterone Plus Placebo (T-P)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Depotestosterone Plus Anastrozole (T-A)		Depotestosterone Plus Placebo (T-P)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/19 (0%)

Limitations/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.