Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days

• Sponsor: Procter and Gamble (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00791388
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 5
• Duration (Months): 5
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo; Drug: PG-760564; Drug: PG-760564; Drug: PG-760564; Drug: PG-760564	Phase 1

Detailed Description

This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses). The study is a multiple rising dose (MRD) study of active drug vs. placebo.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Jan 1, 2006
• Actual Study Completion Date: Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo placebo capsule	Drug: Placebo; oral capsule, 2x/day for 14 days
Experimental: 50 mg PG 760564 50 mg PG 760564 active	Drug: PG-760564; oral capsule, 50 mg, 2x/day for 14 days
Experimental: 100 mg PG 760564 100 mg PG 760564 active	Drug: PG-760564; oral capsule, 100mg, 2x/day for 14 days
Experimental: 200 mg PG 760564 200 mg PG 760564 active	Drug: PG-760564; oral capsule, 200 mg, 2x/day for 14 days
Experimental: 400 mg PG 760564 400 mg PG 760564 active	Drug: PG-760564; oral capsule, 400 mg, 2x/day for 14 days

Outcome Measures

Primary Outcome Measures

1. AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14 [14 days]

   the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours

2. Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14 [12 hours on Day 14]

   Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14

3. Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14 [12 Hours on Day 14]

   the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14

4. t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14 [over a Dosing Interval (τ = 12 Hours) on Day 14]

   t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy males and surgically sterile or post-menopausal (last menstrual period > 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening;

• Who have not used tobacco or nicotine-containing products within the past 3 months;

• Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study;

• Who have a body mass index (BMI) between 18 and 32 kg/m2.

Exclusion Criteria:

• History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;

• History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;

• History of autoimmune disease;

• History of immunodeficiency or of unusual susceptibility to infectious diseases;

• History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);

• Any history of hypersensitivity or clinically significant allergy to any drug;

• Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;

• Family history of sudden death;

• History of uveitis or inflammatory ocular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stuart I Harris, MD, PhD	Miami	Florida	United States	33126

Sponsors and Collaborators

• Procter and Gamble

Investigators

• Study Director: William S Aronstein, MD, PhD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00791388
• Other Study ID Numbers: 2005046
• First Posted: Nov 14, 2008
• Last Update Posted: Nov 4, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by , ,: Pharmacokinetics

Study Results

Participant Flow

Pre-assignment Detail	Each Subject enrolled in the study, participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)

Arm/Group Title	Placebo	50 mg PG 760564	100 mg PG 760564	200 mg PG 760564	400 mg PG 760564
Arm/Group Description	placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.	50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)	100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)	200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)	400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
Period Title: Period 1 - 50 mg Dose Group
STARTED	3	8	0	0	0
COMPLETED	3	7	0	0	0
NOT COMPLETED	0	1	0	0	0
Period Title: Period 1 - 50 mg Dose Group
STARTED	3	0	8	0	0
COMPLETED	2	0	8	0	0
NOT COMPLETED	1	0	0	0	0
Period Title: Period 1 - 50 mg Dose Group
STARTED	3	0	0	8	0
COMPLETED	3	0	0	8	0
NOT COMPLETED	0	0	0	0	0
Period Title: Period 1 - 50 mg Dose Group
STARTED	4	0	0	0	8
COMPLETED	4	0	0	0	4
NOT COMPLETED	0	0	0	0	4

Baseline Characteristics

Arm/Group Title	Placebo	50 mg PG 760564	100 mg PG 760564	200 mg PG 760564	400 mg PG 760564	Total
Arm/Group Description	placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.	50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)	100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)	200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)	400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)	Total of all reporting groups
Overall Participants	13	8	8	8	8	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	13 100%	8 100%	8 100%	8 100%	8 100%	45 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.6 (7.3)	35.0 (5.8)	29.9 (7.4)	36.3 (6.5)	36.9 (5.8)	34.5 (6.8)
Sex: Female, Male (Count of Participants)
Female	1 7.7%	0 0%	0 0%	0 0%	1 12.5%	2 4.4%
Male	12 92.3%	8 100%	8 100%	8 100%	7 87.5%	43 95.6%
Region of Enrollment (participants) [Number]
United States	13 100%	8 100%	8 100%	8 100%	8 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14
Description	the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

PG 760564 blood plasma concentrations were not measured for the placebo arm

Arm/Group Title	Placebo	50 mg PG 760564	100 mg PG 760564	200 mg PG 760564	400 mg PG 760564
Arm/Group Description	placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.	50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)	100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)	200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)	400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
Measure Participants	0	7	8	8	4
Mean (Standard Deviation) [ng*h/mL]	12090.998 (2926.950)	23472.1329 (9858.248)	30005.781 (9955.931)	50354.938 (9781.333)

2. Primary Outcome

Title	Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14
Description	Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14
Time Frame	12 hours on Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	50 mg PG 760564	100 mg PG 760564	200 mg PG 760564	400 mg PG 760564
Arm/Group Description	placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.	50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)	100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)	200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)	400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
Measure Participants	0	7	8	8	4
Mean (Standard Deviation) [ng/mL]	1601.4 (318.2)	2951.3 (1148.2)	3935.0 (953.1)	7195.0 (279.2)

3. Primary Outcome

Title	Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14
Description	the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14
Time Frame	12 Hours on Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	50 mg PG 760564	100 mg PG 760564	200 mg PG 760564	400 mg PG 760564
Arm/Group Description	placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.	50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)	100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)	200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)	400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
Measure Participants	0	7	8	8	4
Mean (Standard Deviation) [hours]	2.46 (0.98)	2.89 (0.63)	3.01 (0.54)	2.03 (0.82)

4. Primary Outcome

Title	t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14
Description	t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14
Time Frame	over a Dosing Interval (τ = 12 Hours) on Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	50 mg PG 760564	100 mg PG 760564	200 mg PG 760564	400 mg PG 760564
Arm/Group Description	placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.	50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)	100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)	200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)	400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
Measure Participants	0	7	8	8	4
Mean (Standard Deviation) [hours]	9.411 (2.640)	7.882 (1.814)	10.223 (3.947)	9.701 (1.714)

Adverse Events

Arm/Group Title	Placebo		50 mg PG 760564		100 mg PG 760564		200 mg PG 760564		400 mg PG 760564
Arm/Group Description	placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.		50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)		100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)		200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)		400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
All Cause Mortality
	Placebo		50 mg PG 760564		100 mg PG 760564		200 mg PG 760564		400 mg PG 760564
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		50 mg PG 760564		100 mg PG 760564		200 mg PG 760564		400 mg PG 760564
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		50 mg PG 760564		100 mg PG 760564		200 mg PG 760564		400 mg PG 760564
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/13 (53.8%)		7/8 (87.5%)		7/8 (87.5%)		8/8 (100%)		8/8 (100%)
Blood and lymphatic system disorders
Lymph node pain	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Thrombocytopenia	0/13 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Cardiac disorders
Ventricular extrasystoles	0/13 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Eye disorders
Conjunctival haemorrhage	0/13 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Ocular discomfort	1/13 (7.7%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Gastrointestinal disorders
Toothache	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	2/8 (25%)	2
Diarrhoea	0/13 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Flatulence	0/13 (0%)	0	0/8 (0%)	0	2/8 (25%)	2	0/8 (0%)	0	0/8 (0%)	0
Abdominal pain	0/13 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Abdominal pain lower	0/13 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Abdominal pain upper	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Vomiting	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Lip Dry	2/13 (15.4%)	2	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Chapped lips	1/13 (7.7%)	1	0/8 (0%)	0	0/8 (0%)	0	2/8 (25%)	2	0/8 (0%)	0
Stomatitis	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	2/8 (25%)	2
General disorders
Application site erythema	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Chills	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Pyrexia	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Tenderness	0/13 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Infections and infestations
Folliculitis	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Clostridium colitis	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Dental caries	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	2/8 (25%)	2
Paronychia	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Upper respiratory tract infection	0/13 (0%)	0	2/8 (25%)	2	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Investigations
Faecal occult blood positive	2/13 (15.4%)	2	0/8 (0%)	0	2/8 (25%)	2	2/8 (25%)	2	1/8 (12.5%)	1
Alanine aminotransferase increased	0/13 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
White blood cell count increased	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Metabolism and nutrition disorders
Decreased appetite	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	0/13 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Nervous system disorders
Lethargy	1/13 (7.7%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Headache	0/13 (0%)	0	0/8 (0%)	0	2/8 (25%)	2	1/8 (12.5%)	1	3/8 (37.5%)	3
Dizziness	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	2/8 (25%)	2
Respiratory, thoracic and mediastinal disorders
Cough	0/13 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	1/8 (12.5%)	1	2/8 (25%)	2
Dry throat	1/13 (7.7%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Pharyngolaryngeal pain	0/13 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0
Throat irritation	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Skin and subcutaneous tissue disorders
Dermatitis acneiform	2/13 (15.4%)	2	6/8 (75%)	6	1/8 (12.5%)	1	7/8 (87.5%)	7	4/8 (50%)	4
Dry skin	1/13 (7.7%)	1	0/8 (0%)	0	4/8 (50%)	4	0/8 (0%)	0	1/8 (12.5%)	1
Eczema	1/13 (7.7%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Erythema	1/13 (7.7%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Rash papular	1/13 (7.7%)	1	1/8 (12.5%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0
Acne	1/13 (7.7%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	2/8 (25%)	2
Vascular disorders
Hot flush	0/13 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Hypertension	1/13 (7.7%)	1	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Data, calculations, interpretations, opinions, and recommendations are the property of P&GP. In the event study results are published in the scientific literature by P&GP, acknowledgment will be made to the Investigator(s) in the accepted style, as appropriate.