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CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT00729859
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
31
Enrollment
3
Arms
17
Duration (Months)

Study Details

Study Description

Brief Summary

The original purpose of this research study was to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge would be used to help understand the effects of T and estrogen on cardiovascular (heart and blood vessel) disease, and to help in the development of a safe male hormonal contraceptive.

The effect of androgens on the number of circulating endothelial progenitor (CEP) cells would best be observed in group 1 (placebo). Upon observation of group 1 under original protocol, changes in CEP cells were not significant but there were changes in markers of inflammation, lipids, and HDL protein composition. A modification to the protocol and title were made to reflect this for groups 2 and 3: Hormonal regulation of HDL-C in Men.

Condition or Disease Intervention/Treatment Phase
  • Drug: Acyline
  • Drug: Acyline + Testosterone gel
  • Drug: Acyline + testosterone gel + anastrozole
 Phase 2

Detailed Description

We will be administering three drugs: testosterone gel (T), anastrozole, and acyline. We want to see their effects on stem cells and hormone levels in the blood. Acyline suppress luteinizing hormone(LH) and follicle-stimulating hormone(FSH), which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore acyline blocks testosterone production. Some men may experience side effects such as hot flashes or irritability from the low levels of T caused by acyline. We are studying whether adding T to acyline will reduce or eliminate these side effects.

Since heart disease is a common problem in men we want to know about the effects of male hormonal contraception on the cardiovascular system. One way to evaluate these risks is to measure the number of progenitor cells and the types of cholesterol in the blood. Progenitor cells are cells that travel in the blood and go to areas of blood vessel injury to help repair the damage amd may help prevent heart attacks and stokes. Some studies suggest that T administration may increase the number of these cells in the blood but other studies have shown that estrogen may be responsible for this effect. In addition, T and estrogen may affect the amount and type of HDL cholesterol in the blood. This is the "good" cholesterol that is thought to protect people from heart attacks and strokes. Therefore, more studies to test the effects of T and estrogen on progenitor cells in the blood and to understand HDL cholesterol in men receiving testosterone are needed.

Acyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. So far, over 125 men have received acyline. Anastrozole is a drug that blocks the production of estrogen from testosterone. Anastrozole has been given to men safely in the past. Anastrozole is not approved for use in men and is also an experimental drug. Testosterone gel will also be used in this study. It is FDA approved for use in men with low testosterone levels.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men Title Changed With New Protocol (12/14/09): Hormonal Regulation of HDL-C in Men
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Acyline 300 µg/kg injections every two weeks (2 doses) + placebo (no active ingredients) gel daily for 28 days + oral placebo pill daily for 28 days

Drug: Acyline
Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + placebo Testosterone gel daily for 28 days + placebo oral anastrozole pill daily for 28 days
Other Names:
  • placebo testosterone gel
  • placebo pill

    		•
    Experimental: Group 2

    Acyline 300 µg/kg injections every two weeks (2 doses) + Testosterone gel 100 mg daily for 28 days + oral placebo pill daily for 28 days

    Drug: Acyline + Testosterone gel
    Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + placebo oral pill 1 mg daily for 28 days
    Other Names:
  • Acyline
  • testosterone gel

    		•
    Experimental: Group 3

    Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + oral anastrozole pill 1 mg daily for 28 days

    Drug: Acyline + testosterone gel + anastrozole
    Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + oral anastrozole pill 1 mg daily for 28 days
    Other Names:
  • Acyline
  • Testosterone gel
  • Anastrozole

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endothelial Progenitor Cells [Baseline, Day 28]

      Number of CD33 + CD134+ cells as a percentage of all lymphocytes

    Secondary Outcome Measures

    1. Follicle Stimulating Hormone (FSH) [Baseline, 28 days]

    2. Luteinizing Hormone Concentration (LH) [Baseline, Day 28]

    3. Testosterone Concentration [Baseline, Day 28]

    4. Estradiol Concentration [Baseline, Day 28]

    5. Sex Hormone Binding Globulin (SHBG) [Baseline, Day 28]

    6. Quantitative Insulin Sensitivity Check Index (QUICKI) [Baseline, Day 28, Day 56]

      QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.

    7. Homeostasis Model of Insulin Resistance (HOMA-IR) [Baseline, Day 28, Day 56]

      HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.

    8. Fasting Serum Insulin [Baseline, Day 28, Day 56]

    9. Fasting Lipid Levels [Baseline, Day 28, Day 56]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Males age 18-55 years

    • Normal serum total testosterone (300 ng/dl-1000 ng/dl)

    • Normal LH and FSH levels

    • Taking no regular medications

    • Normal baseline serum hematology, chemistry and liver function tests

    • Agrees not to donate blood during the study

    • Agrees to use a form of contraception during the study

    • Subject must be able to comply with all study procedures

    Exclusion Criteria:

    • Clinically significant screening assessments or other relevant disease, allergy or surgery, as revealed by history, physical examination and/or laboratory assessments, which may limit participation or prevent completion of the study

    • History of prostate cancer, breast cancer, or benign prostatic hypertrophy

    • Prostate-specific antigen (PSA) > 3.0

    • History of regular, chronic testosterone or anabolic steroid use in the past year

    • Chronic medical illness, prostate disease, or cardiovascular disease

    • History of a bleeding disorder or need for anticoagulation

    • Skin condition that might interfere with or be exacerbated by T gel use

    • Sitting systolic blood pressure > 180mm Hg or <90 mm Hg or sitting diastolic blood pressure >110 mm Hg or < 60 mm Hg.

    • History of clinically significant, untreated sleep apnea

    • Participation in another drug-related research study within the past 2 months

    • Participating in a regular physical relationship with a pregnant woman

    • History of hypersensitivity to any of the study medications (T gel, anastrozole, acyline)

    • History of medical or surgical therapy for benign prostatic hypertrophy

    • Hematocrit > 55%

    • History of drug or alcohol abuse within last 6 months

    • Abnormal digital rectal exam at screening

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Washington
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Principal Investigator: Stephanie Page, MD, PhD, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Stephanie T. Page, Associate Professor, University of Washington
    ClinicalTrials.gov Identifier:
    NCT00729859
    Other Study ID Numbers:
    • 33853-A
    • U54HD042454
    First Posted:
    Aug 8, 2008
    Last Update Posted:
    Oct 12, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by Stephanie T. Page, Associate Professor, University of Washington
    HDL
    Insulin sensitivity
    testosterone
    estradiol
    cholesterol
    Additional relevant MeSH terms:
    Methyltestosterone
    Anastrozole
    Testosterone
    Testosterone undecanoate
    Testosterone enanthate
    Testosterone 17 beta-cypionate
    Acyline

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited using rosters from prior research studies, newspaper and online advertisements. Recruitment began December 2008 and ended March 2010.
    Pre-assignment Detail Before study procedures,2 withdrew consent and 1 was withdrawn by the investigator for missing appointments.4 failed inclusion criteria(1-anemia,1-low testosterone,1-high BMI,1-medications. 31 men enrolled. 22 men completed.
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Anastrazole Pill
    Arm/Group Description Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
    Period Title: Overall Study
    STARTED 8 8 8
    COMPLETED 8 6 8
    NOT COMPLETED 0 2 0

    Baseline Characteristics

    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Anastrazole Pill Total
    Arm/Group Description Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days Total of all reporting groups
    Overall Participants 8 8 8 24
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    8
    100%
    8
    100%
    8
    100%
    24
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    38.5
    (10.6)
    24.3
    (4.0)
    25.8
    (8.4)
    30.0
    (10.5)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    8
    100%
    8
    100%
    8
    100%
    24
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    1
    12.5%
    1
    12.5%
    2
    8.3%
    Not Hispanic or Latino
    8
    100%
    7
    87.5%
    7
    87.5%
    22
    91.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    2
    25%
    1
    12.5%
    3
    12.5%
    White
    8
    100%
    6
    75%
    7
    87.5%
    21
    87.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    26.2
    (2.5)
    27.1
    (3.8)
    23.7
    (2.1)
    25.5
    (3.0)

    Outcome Measures

    1. Primary Outcome
    Title Endothelial Progenitor Cells
    Description Number of CD33 + CD134+ cells as a percentage of all lymphocytes
    Time Frame Baseline, Day 28

    Outcome Measure Data

    Analysis Population Description
    Statistical analyses were limited to changes from baseline within a given group and between-group comparisons were not performed
    Arm/Group Title Group 1: Acyline + Placebo Gel + Placebo Pill Group 2: Acyline + T-gel 10g/Day + Placebo Pill Group 3: Acyline + T-gel + Oral Anastrozole 1mg
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Acyline SQ inj. Day 0 & 14 + T-gel and placebo pill for 28 days Acyline SQ inj. Day 0 & 14 + T-gel and anastrozole for 28 days
    Measure Participants 8 0 0
    Baseline
    0.101
    (0.032)
    Day 28
    0.081
    (0.040)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group 1: Acyline + Placebo Gel + Placebo Pill
    Comments p value for the difference = 0.28
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.28
    Comments
    Method paired t-test
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.02
    Confidence Interval (2-Sided) 95%
    0.005 to 0.035
    Parameter Dispersion Type: Standard Deviation
    Value: 0.0075
    Estimation Comments
    2. Secondary Outcome
    Title Follicle Stimulating Hormone (FSH)
    Description
    Time Frame Baseline, 28 days

    Outcome Measure Data

    Analysis Population Description
    Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel Group 3: Acyline, Testosterone Gel, Anastrazole Pill
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrazole pill 1 mg for 28 days
    Measure Participants 8 6 8
    Baseline
    4.2
    (2.4)
    2.9
    (1.3)
    2.5
    (0.9)
    Day 28
    0.42
    (0.7)
    0.39
    (0.5)
    0.87
    (0.8)
    3. Secondary Outcome
    Title Luteinizing Hormone Concentration (LH)
    Description
    Time Frame Baseline, Day 28

    Outcome Measure Data

    Analysis Population Description
    The analysis was per protocol. Following screening, the first 8 subjects were assigned to group I, and subsequent subjects enrolled were randomly assigned to either group 2 or 3.
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel Group 3: Acyline, Testosterone Gel, Anastrozole
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
    Measure Participants 8 6 8
    Baseline
    4.3
    (2.3)
    4.7
    (1.9)
    4.4
    (2.2)
    Day 28
    0.31
    (0.2)
    0.69
    (1.2)
    1.55
    (1.6)
    4. Secondary Outcome
    Title Testosterone Concentration
    Description
    Time Frame Baseline, Day 28

    Outcome Measure Data

    Analysis Population Description
    Per protocol, the first 8 subjects were assigned to group I. Subsequent subjects were randomized to group 2 or group 3.
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel Group 3: Acyline, Testosterone Gel, Anastrozole
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
    Measure Participants 8 6 8
    Baseline testosterone concentration
    15.4
    (3.4)
    16.3
    (3.3)
    16.5
    (2.6)
    Day 28 testosterone concentration
    0.8
    (0.8)
    17.8
    (5.5)
    19.0
    (7.3)
    5. Secondary Outcome
    Title Estradiol Concentration
    Description
    Time Frame Baseline, Day 28

    Outcome Measure Data

    Analysis Population Description
    Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel Group 3: Acyline, Testosterone Gel, Anastrozole Pill
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
    Measure Participants 8 6 8
    Baseline
    95.4
    (18.2)
    117.8
    (28.6)
    96.3
    (21.9)
    Day 28
    31.9
    (11.2)
    109.0
    (28.8)
    36.5
    (14.3)
    6. Secondary Outcome
    Title Sex Hormone Binding Globulin (SHBG)
    Description
    Time Frame Baseline, Day 28

    Outcome Measure Data

    Analysis Population Description
    Per protocol, the first 8 subjects were assigned to Group I. Subsequent subjects were randomly assigned to Group 2 or Group 3.
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel Group 3: Acyline, Testosterone Gel, Anastrozole Pill
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
    Measure Participants 8 6 8
    Baseline
    34.9
    (17.1)
    23.0
    (10.9)
    27.6
    (6.3)
    Day 28
    37.5
    (16.4)
    22.1
    (10.1)
    25.1
    (4.7)
    7. Secondary Outcome
    Title Quantitative Insulin Sensitivity Check Index (QUICKI)
    Description QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.
    Time Frame Baseline, Day 28, Day 56

    Outcome Measure Data

    Analysis Population Description
    per protocol
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Oral Anastrozole
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
    Measure Participants 8 6 8
    Baseline
    0.36
    (0.03)
    0.35
    (0.02)
    0.36
    (0.02)
    Day 28
    0.34
    (0.03)
    0.35
    (0.02)
    0.38
    (0.02)
    Day 56
    0.35
    (0.03)
    0.35
    (0.02)
    0.36
    (0.02)
    8. Secondary Outcome
    Title Homeostasis Model of Insulin Resistance (HOMA-IR)
    Description HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.
    Time Frame Baseline, Day 28, Day 56

    Outcome Measure Data

    Analysis Population Description
    per protocol
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Oral Anastrozole
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
    Measure Participants 8 6 8
    Baseline
    1.8
    (0.9)
    2.0
    (0.9)
    1.6
    (0.6)
    Day 28
    2.4
    (1.0)
    1.9
    (0.9)
    1.4
    (0.8)
    Day 56
    2.2
    (0.9)
    1.9
    (0.9)
    1.7
    (0.8)
    9. Secondary Outcome
    Title Fasting Serum Insulin
    Description
    Time Frame Baseline, Day 28, Day 56

    Outcome Measure Data

    Analysis Population Description
    per protocol
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Oral Anastrozole
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
    Measure Participants 8 6 8
    Baseline
    54
    (26)
    65
    (28)
    50
    (16)
    Day 28
    69
    (25)
    59
    (26)
    42
    (23)
    Day 56
    54
    (26)
    64
    (27)
    50
    (16)
    10. Secondary Outcome
    Title Fasting Lipid Levels
    Description
    Time Frame Baseline, Day 28, Day 56

    Outcome Measure Data

    Analysis Population Description
    per protocol
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Oral Anastrozole
    Arm/Group Description Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.
    Measure Participants 8 6 8
    Total cholesterol Day 0
    4.97
    (1.1)
    4.48
    (0.4)
    4.56
    (1.5)
    Total cholesterol Day 28
    5.44
    (1.2)
    4.51
    (0.3)
    4.56
    (0.9)
    Total cholesterol Day 56
    4.95
    (1.1)
    4.14
    (0.6)
    4.27
    (1.2)
    LDL choesterol Day 0
    2.95
    (0.8)
    2.77
    (0.3)
    2.67
    (1.3)
    LDL cholesterol Day 28
    3.29
    (0.7)
    2.80
    (0.2)
    2.75
    (0.8)
    LDL cholesterol Day 56
    2.87
    (0.5)
    2.49
    (0.5)
    2.51
    (1.0)
    HDL cholesterol Day 0
    1.19
    (0.2)
    1.32
    (0.2)
    1.40
    (0.2)
    HDL cholesterol Day 28
    1.37
    (0.2)
    1.32
    (0.1)
    1.32
    (0.2)
    HDL cholesterol Day 56
    1.19
    (0.2)
    1.32
    (0.2)
    1.30
    (0.2)
    Triglycerides Day 0
    1.79
    (2.1)
    0.82
    (0.2)
    1.08
    (0.5)
    Triglycerides Day 28
    1.73
    (1.4)
    0.86
    (0.3)
    1.08
    (0.4)
    Triglycerides Day 56
    1.89
    (2.3)
    0.80
    (0.4)
    1.02
    (0.3)

    Adverse Events

    Time Frame Dec 2008 - May 2010
    Adverse Event Reporting Description
    Arm/Group Title Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Anastrazole Pill
    Arm/Group Description Acyline 300 µg/kg injections Day 0 & 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days Acyline 300 µg/kg injections Day 0 & 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days Acyline 300 μg/kg injections Day 0 & 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days
    All Cause Mortality
    Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Anastrazole Pill
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Anastrazole Pill
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/6 (0%) 0/8 (0%)
    Other (Not Including Serious) Adverse Events
    Group 1: Acyline + Placebo Gel, Placebo Pill Group 2: Acyline, Testosterone Gel, Placebo Pill Group 3: Acyline, Testosterone Gel, Anastrazole Pill
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/8 (75%) 1/6 (16.7%) 2/8 (25%)
    Endocrine disorders
    emotional lability, irritability 1/8 (12.5%) 1 0/6 (0%) 0 1/8 (12.5%) 1
    fatigue 2/8 (25%) 2 1/6 (16.7%) 1 0/8 (0%) 0
    hot flashes 3/8 (37.5%) 3 0/6 (0%) 0 0/8 (0%) 0
    lightheadedness, clammy 1/8 (12.5%) 1 0/6 (0%) 0 0/8 (0%) 0
    low libido 4/8 (50%) 4 0/6 (0%) 0 1/8 (12.5%) 1
    Skin and subcutaneous tissue disorders
    itching at acyline site 1/8 (12.5%) 1 1/6 (16.7%) 1 0/8 (0%) 0
    skin irritation, gel application site 1/8 (12.5%) 1 0/6 (0%) 0 1/8 (12.5%) 1
    itching rash 1/8 (12.5%) 1 0/6 (0%) 0 0/8 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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 Stephanie T. Page, MD, PhD
    Organization University of Washington
    Phone 206-616-0483
    Email page@u.washington.edu
    Responsible Party:
    Stephanie T. Page, Associate Professor, University of Washington
    ClinicalTrials.gov Identifier:
    NCT00729859
    Other Study ID Numbers:
    • 33853-A
    • U54HD042454
    First Posted:
    Aug 8, 2008
    Last Update Posted:
    Oct 12, 2012
    Last Verified:
    Sep 1, 2012