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CompletedNCT01370369Updated Sep 13, 2017Results posted

Efficacy, Pharmacokinetics and Safety of Testosterone

A Phase 2 interventional study of Testosterone gel (FE 99903) in Testicular Hypogonadism, sponsored by Ferring Pharmaceuticals. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-13.

Sponsored by Ferring Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations \< 297 ng/dL.

02

Conditions studied

  • Testicular Hypogonadism

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03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 20 is below the median of 56 across 260 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Ages 18-65
  • History of hypogonadism
  • In good health based on medical history, physical examination and clinical laboratory tests
  • Screening morning serum testosterone ≤ 297 ng/dL
  • One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)
  • Body mass index (BMI) between 18 and 31

Exclusion criteria

Exclusion Criteria:

  • Prostate cancer
  • Palpable prostatic mass(es)
  • Generalized skin irritation or significant skin disease
  • Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, finasteride, ketoconazole)
  • Clinically significant anemia or renal dysfunction
  • Hyperparathyroidism or uncontrolled diabetes
  • Serum PSA Levels; ≥ 4ng/mL
  • History of cardiovascular disease
  • Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)
  • Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Single Testosterone Dose (Inner Thigh)

    Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a seven day washout period.

    Drug: Testosterone gel (FE 99903)

  • Experimental
    Single Testosterone Dose (Abdomen)

    Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a seven day washout period.

    Drug: Testosterone gel (FE 99903)

  • Experimental
    Single Testosterone Dose (shoulder/upper arm)

    Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.

    Drug: Testosterone gel (FE 99903)

  • Experimental
    Testosterone 1.25

    Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke) applied once daily for 10 consecutive days to the shoulder/upper arm.

    Drug: Testosterone gel (FE 99903)

  • Experimental
    Testosterone 2.50

    Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes) applied once daily for 10 consecutive days to the shoulder/upper arm.

    Drug: Testosterone gel (FE 99903)

  • Experimental
    Testosterone 3.75

    Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes) applied once daily for 10 consecutive days to the shoulder/upper arm.

    Drug: Testosterone gel (FE 99903)

Interventions

  • DrugTestosterone gel (FE 99903)
06

What researchers measure

Primary outcomes

  1. Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.

    Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome.

    Time frame: From Baseline to Day 43

Secondary outcomes

  1. Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13

  2. Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13

  3. Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13

  4. Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

  5. Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

  6. Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

  7. Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

  8. Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

  9. Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

  10. Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

  11. Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

  12. Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

    The data were presented using descriptive statistics for this outcome.

    Time frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43

  13. Frequency of Adverse Events (AEs)

    The data were presented using descriptive statistics for this outcome.

    Time frame: From Baseline to Day 43

07

Results

Posted Aug 1, 2017

Participant flow

The study was conducted at one study site in the US. Out of 42 subjects screened, 20 subjects were enrolled in the study.

Participant flow — Overall Study
MilestoneTestosterone Topical
Started20
Completed20
Not completed0

Outcome measures

PrimaryResponder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.

Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome.

Time frame:
From Baseline to Day 43
Reported as:
Number · percentage of subjects
Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.
percentage of subjectsTestosterone 1.25Testosterone 2.50Testosterone 3.75
Cave73.777.775.0
Cmin20.040.055.0
SecondaryPharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13
Reported as:
Mean · ng/dL
Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.
ng/dLSingle Testosterone Dose (Inner Thigh)Single Testosterone Dose (Abdomen)Single Testosterone Dose (Shoulder/Upper Arm)
Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.519 ± 171451 ± 157926 ± 737
SecondaryPharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13
Reported as:
Median · hour
Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.
hourSingle Testosterone Dose (Inner Thigh)Single Testosterone Dose (Abdomen)Single Testosterone Dose (Shoulder/Upper Arm)
Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.24.0 (0.0 to 24.8)9.0 (2.0 to 24.0)11.0 (4.0 to 24.7)
SecondaryPharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13
Reported as:
Mean · ng*hour/dL
Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.
ng*hour/dLSingle Testosterone Dose (Inner Thigh)Single Testosterone Dose (Abdomen)Single Testosterone Dose (Shoulder/Upper Arm)
Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.9472 ± 23068918 ± 292413368 ± 7163
SecondaryPharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Reported as:
Mean · ng/dL
Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
ng/dLTestosterone 1.25Testosterone 2.50Testosterone 3.75
Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.586 ± 290907 ± 7831258 ± 774
SecondaryPharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Reported as:
Median · hour
Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
hourTestosterone 1.25Testosterone 2.50Testosterone 3.75
Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.6.0 (0.0 to 24.0)4.0 (0.0 to 24.9)6.0 (0.0 to 24.0)
SecondaryPharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Reported as:
Mean · ng*hour/dL
Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
ng*hour/dLTestosterone 1.25Testosterone 2.50Testosterone 3.75
Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.9229 ± 294612148 ± 630017625 ± 9250
SecondaryPharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Reported as:
Mean · pg/mL
Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
pg/mLTestosterone 1.25Testosterone 2.50Testosterone 3.75
Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.134 ± 90229 ± 273382 ± 342
SecondaryPharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Reported as:
Median · hour
Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
hourTestosterone 1.25Testosterone 2.50Testosterone 3.75
Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.6.0 (0.0 to 24.3)7.0 (0.0 to 24.9)6.0 (0.0 to 24.0)
SecondaryPharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Reported as:
Mean · pg*hour/mL
Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
pg*hour/mLTestosterone 1.25Testosterone 2.50Testosterone 3.75
Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.1765 ± 7812655 ± 20784663 ± 3517
SecondaryPharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Reported as:
Mean · ng/dL
Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
ng/dLTestosterone 1.25Testosterone 2.50Testosterone 3.75
Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.64.4 ± 32.293.3 ± 51.9120 ± 60
SecondaryPharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Reported as:
Median · hour
Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
hourTestosterone 1.25Testosterone 2.50Testosterone 3.75
Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.6.0 (0.0 to 24.4)4.0 (0.0 to 24.9)6.0 (0.0 to 25.0)
SecondaryPharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.

The data were presented using descriptive statistics for this outcome.

Time frame:
Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43
Reported as:
Mean · ng*hour/dL
Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
ng*hour/dLTestosterone 1.25Testosterone 2.50Testosterone 3.75
Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.1063 ± 4791458 ± 7261974 ± 890
SecondaryFrequency of Adverse Events (AEs)

The data were presented using descriptive statistics for this outcome.

Time frame:
From Baseline to Day 43
Reported as:
Number · number of event
Frequency of Adverse Events (AEs)
number of eventTestosterone 1.25Testosterone 2.50Testosterone 3.75
Frequency of Adverse Events (AEs)122

Adverse events

Collected over Overall Treatment Period (43 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Testosterone 1.25—0/20 (0%)1/20 (5%)
Testosterone 2.50—0/20 (0%)2/20 (10%)
Testosterone 3.75—0/20 (0%)2/20 (10%)
Most frequent other events
Most frequent other events
EventTestosterone 1.25Testosterone 2.50Testosterone 3.75
Prostatic specific antigen increasedInvestigations0/200/202/20
Abdominal discomfortGastrointestinal disorders0/201/200/20
Liver function test abnormalInvestigations1/200/200/20
Nipple painReproductive system and breast disorders0/201/200/20

Baseline characteristics

The data are presented for Intent-to-treat (ITT) population, which comprised of all subjects who received at least one dose of the Investigational Medicinal Product (IMP). In this study, the safety, ITT, full analysis set (FAS) and per protocol (PP) populations were identical.

Age, Continuous
Age, Continuous(year)Testosterone Topical
Mean47.9 ± 9.9
Sex: Female, Male
Sex: Female, Male(Participants)Testosterone Topical
Female0
Male20
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Testosterone Topical
Hispanic or Latino3
Not Hispanic or Latino17
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Testosterone Topical
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American6
White13
More than one race0
Unknown or Not Reported0
Body Mass Index (BMI)
Body Mass Index (BMI)(Kg/m^2)Testosterone Topical
Mean28.3 ± 2.3
Height
Height(Inch)Testosterone Topical
Mean69.7 ± 3.2
Weight
Weight(lbs)Testosterone Topical
Mean196.2 ± 23.3
08

Study locations

1 site
  • AccuMed Research Associates
    Garden City, New York, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01370369
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Jun 9, 2011
Start date
May 2011
Primary completion
Jul 2011
Completion
Jul 2011
Results posted
Aug 1, 2017
Last update
Sep 13, 2017

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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