Study: NCT00729859

Adverse event: emotional lability, irritability
Serious: no
Organ System: Endocrine disorders
Notes: This is expected in group 1 subjects (hypogonadal). The group 3 subject with emotional lability also reported skin irritation at the testosterone gel site.
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: Endocrine disorders
Notes: Fatigue is anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel. The group 2 subject also reported studying late and spending the night in the library during midterm week. Fatigue is described in the consent as a possibility.
Frequency: 2 affected / 8 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Notes: Hot flashes are anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel). This is described in the consent.
Frequency: 3 affected / 8 at risk

Adverse event: itching at acyline site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The written consent describes itchiness at the site in most men. One (group 2)is not counted here, but is described in "participant flow". Symptoms had resolved on Day 14 but he withdrew consent before the second acyline injection.
Frequency: 1 affected / 8 at risk

Adverse event: lightheadedness, clammy
Serious: no
Organ System: Endocrine disorders
Notes: Mild symptoms occurred two days and were deemed possibly related to the drug. No action or medications were required in this group I (hypogonadal symptoms expected) subject.
Frequency: 1 affected / 8 at risk

Adverse event: low libido
Serious: no
Organ System: Endocrine disorders
Notes: Low libido is anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel). This is described in the consent.
Frequency: 4 affected / 8 at risk

Adverse event: skin irritation, gel application site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One(group 1) complaint of itchiness;one(group 3) complaint of dry skin at testosterone gel application site. Both subjects were instructed to apply elsewhere; complaints were resolved with no further symptoms at old and new application sites.
Frequency: 1 affected / 8 at risk

Adverse event: itching rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: Endocrine disorders
Notes: Fatigue is anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel. The group 2 subject also reported studying late and spending the night in the library during midterm week. Fatigue is described in the consent as a possibility.
Frequency: 1 affected / 6 at risk

Adverse event: itching at acyline site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The written consent describes itchiness at the site in most men. One (group 2)is not counted here, but is described in "participant flow". Symptoms had resolved on Day 14 but he withdrew consent before the second acyline injection.
Frequency: 1 affected / 6 at risk

Adverse event: emotional lability, irritability
Serious: no
Organ System: Endocrine disorders
Notes: This is expected in group 1 subjects (hypogonadal). The group 3 subject with emotional lability also reported skin irritation at the testosterone gel site.
Frequency: 1 affected / 8 at risk

Adverse event: low libido
Serious: no
Organ System: Endocrine disorders
Notes: Low libido is anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel). This is described in the consent.
Frequency: 1 affected / 8 at risk

Adverse event: skin irritation, gel application site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One(group 1) complaint of itchiness;one(group 3) complaint of dry skin at testosterone gel application site. Both subjects were instructed to apply elsewhere; complaints were resolved with no further symptoms at old and new application sites.
Frequency: 1 affected / 8 at risk