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PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01364623
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
Acerus Pharmaceuticals Corporation

Brief Summary:

The purpose of this study is to assess the bioavailability of total testosterone through pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2 b) multiple administration TBS-2.

In addition, assessing the bioavailability of free testosterone, dihydrotestosterone, SHBG and estradiol through pharmacokinetic profiles will also be conducted.

Condition or disease Intervention/treatment Phase
Female Sexual Dysfunction Drug: Low dose testosterone nasal gel Drug: Medium dose testosterone nasal gel Drug: High dose testosterone nasal gel Phase 1

Detailed Description:

This is a 2 Period study that requires overnight stays in clinic. Blood samples are required at all visits including sampling at predefined time periods during the overnight stays.

Period I

Subjects will be checked-in on Day 1 Period I to start their baseline testosterone measurement (dependant on menstrual cycle, preferably within 48hr of start of the menstrual cycle). They will remain institutionalized until Day 4 morning, and will be checked out after the 48 hour blood draw and study close-out for those that do not continue with Period II.

Period II (Multi-Dose)

Subjects will be institutionalized starting on Day 1 of Visit 3 until Day 5 morning of Visit 3, and will be checked out after the 48 hour blood draw and study close-out.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels
Study Start Date : September 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Low dose TBS-2 Drug: Low dose testosterone nasal gel
Single dose administration
Other Name: TBS-2

Experimental: Medium dose TBS-2 Drug: Medium dose testosterone nasal gel
Single dose Administration
Other Name: TBS-2

Drug: Medium dose testosterone nasal gel
multiple dose administration
Other Name: TBS-2

Experimental: High dose TBS-2 Drug: High dose testosterone nasal gel
single dose Administration
Other Name: TBS-2

Primary Outcome Measures :
  1. Area under the plasma concentration curve (AUC) of testosterone following TBS-2 [ Time Frame: up to 3 days ]
    The following pharmacokinetic parameters will be calculated: Cmax, Tmax, AUC, half life

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of dihydrotestosterone and estradiol following TBS-2 [ Time Frame: up to 3 days ]
    The following pharmacokinetic parameters will be calculated: AUC, Cmax, Tmax, half life

  2. Number of subjects with adverse events [ Time Frame: Up to 5 days ]
    1. Vital Signs and Adverse Events: Blood Pressure, Body Temperature, Respiratory Rate, Heart Rate.
    2. Otorhinolaryngological examination with the nasal tolerance data presented in summary tables.
    3. Complete Blood Count: white blood count, hemoglobin and hematocrit.
    4. Clinical chemistry profile: Sodium, potassium, chloride, glucose, urea, creatinine, calcium, phosphate, uric acid, total bilirubin, albumin, AST, ALT, ALP, GGT, CK and cholesterol, hormone profiles.
    5. Urinalysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Subjects having regular menstrual cycles between 26-32 days.
  • Women of childbearing potential must agree to use one of the following reliable birth control methods prior to the study, during the study and up until one month after the end of the study:

    • Surgically sterile
    • Intrauterine device in place for at least 3 months prior to study initiation
    • Barrier method (condom with spermicidal agent use by partner)
    • Abstinence
  • Negative for drugs of abuse, hepatitis B-surface antigen, hepatitis C, HIV, and pregnancy (serum ß-HCG).
  • Body Mass Index greater than or equal to 18.5 kg/m² and less than or equal to 35 kg/m².
  • Subjects with a normal ENT exam.
  • Subjects with normal TSH values.
  • No clinically significant findings in the physical examination, 12-lead ECG and vital signs
  • Normal thyroid function. Physiological prolactin concentration.
  • All clinical laboratory test values within the acceptable ranges (any clinically significant findings will require investigator/sponsor approval)
  • Able to understand and provide written informed consent.
  • Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed ICF

Exclusion Criteria

  • Known history of hypersensitivity to Testosterone (e.g. Intrinsa patch) and/or related drugs.
  • Known history of polycystic ovarian syndrome.
  • Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, psychiatric, hematological, reproductive, liver or kidney disease, unless judged not clinically significant by the Principal Investigator or medical designate.
  • Presence of or known history of Estrogen-responsive tumors such as breast cancer and /or history of any cancer, excluding basal cell carcinoma.
  • Known history of frequent clinically significant acne.
  • Known history of hirsutism
  • History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, "nose job", or sinus surgery.
  • Prior nasal fractures.
  • Active allergies, such as rhinitis, rhinorrhea, and nasal congestion.
  • Mucosal inflammatory disorders, specifically pemphigus, and Sjogren's syndrome.
  • Sinus disease, specifically acute sinusitis, chronic sinusitis, or allergic fungal sinusitis.
  • History of nasal disorders or sleep apnea.
  • Use of any form of intra-nasal medication delivery, specifically nasal corticosteroids and oxymetazoline containing nasal sprays
  • History of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies.
  • Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • Any history of drug abuse or alcohol abuse as per DSM-IV criteria within 6 months of study drug administration.
  • Current treatment with any hormone replacement therapy within previous 12 months, treatment with drugs which interfere with metabolism of Testosterone within 30 days of study drug administration and/or any other prescription medications. Difficulty in abstaining from OTC medication for the duration of study.
  • Use of oral, transdermal and implant contraceptives within 30 days prior to drug administration or a depot contraceptives injection within one year prior to drug administration.
  • Evidence of pregnancy or lactation.
  • Subjects who are breast feeding or have breast fed within the last six (6) months prior to the Screening Visit.
  • Administration of another investigational drug within 30 days prior to study medication administration.
  • Blood donation within 56 days prior to study medication administration.
  • Any participation as a plasma donor in a plasmapheresis program within seven days preceding screening in this study.
  • Intolerance to venipuncture.
  • History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.
  • History of Deep Venous Thrombosis or coagulation disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01364623

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United States, Texas
Premier Research International LLC
Austin, Texas, United States, 78705
Sponsors and Collaborators
Acerus Pharmaceuticals Corporation
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Study Director: Natalia Tkachenko, MD Trimel Pharmaceuticals Corporation

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Responsible Party: Acerus Pharmaceuticals Corporation Identifier: NCT01364623     History of Changes
Other Study ID Numbers: TBS-2-2011-01
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Acerus Pharmaceuticals Corporation:

Additional relevant MeSH terms:
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Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents