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Evaluation of Safety and Efficacy of Estetrol in Healthy Men

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.
 
ClinicalTrials.gov Identifier: NCT02718378
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Pantarhei Oncology B.V.

Brief Summary:
The current study is designed as a phase Ib multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of E4 in healthy men after daily oral administration for 28 days.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: estetrol Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase I, Double-blind, Randomised, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Dosages of Estetrol in Healthy Men
Study Start Date : March 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: No added active
placebo without estetrol
Drug: placebo
Active Comparator: estetrol dose level 1
estetrol given in dose level 1
Drug: estetrol
Active Comparator: estetrol dose level 2
estetrol given in dose level 2
Drug: estetrol
Active Comparator: estetrol dose level 3
estetrol given in dose level 3
Drug: estetrol



Primary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) [ Time Frame: 28 days ]
    Changes from baseline measurements considered clinically significant by the Investigator will be reported as AEs.

  2. Change from baseline in hormone levels [ Time Frame: 28 days ]
    The serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH), Estradiol (E2), total testosterone and free testosterone levels (actual values as well as percentage change from pre-dose concentration) will be listed and summarized descriptively by treatment group.


Secondary Outcome Measures :
  1. Change from baseline in haemostasis parameters [ Time Frame: 28 days ]
    The relative change in Activated Protein C (APC)-resistance, prothrombin factor 1 + 2, D-dimer, free Tissue Factor Pathway Inhibitor (TFPI), antothrombin activity, protein S activity and angiotensinogen levels and the actual change from baseline will be calculated by treatment group.

  2. Change from baseline in lipid parameters [ Time Frame: 28 days ]
    The relative change in total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol, Lipoprotein A (Lp(A)) levels and the actual change from baseline will be calculated by treatment group.

  3. Change from baseline in glucose levels [ Time Frame: 28 days ]
    The relative change in glucose levels and the actual change from baseline will be calculated by treatment group.

  4. Change from baseline in bone turnover markers [ Time Frame: 28 days ]
    The relative change in osteocalcin, type I collagen telopeptide (CTX-1) and parathyroid hormone (PTH) and the actual change from baseline will be calculated by treatment group.

  5. Change from baseline in sex-hormone binding globulin (SHBG) levels [ Time Frame: 28 days ]
    The relative change in SHBG levels and the actual change from baseline will be calculated by treatment group.

  6. Pharmacokinetic effect of estetrol [ Time Frame: 28 days ]
    Area under the plasma concentration versus time curve (AUC)

  7. Pharmacokinetic effect of estetrol [ Time Frame: 28 days ]
    Terminal elimination half-life (t1/2)

  8. Pharmacokinetic effect of estetrol [ Time Frame: 28 days ]
    Time to reach Cmax (tmax)

  9. Pharmacokinetic effect of estetrol [ Time Frame: 28 days ]
    Peak plasma concentration (Cmax)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male, age between 40 and 70 years (both inclusive);
  • Good physical and mental health as judged by the Investigator determined by medical history, physical examination (including prostate palpation), clinical laboratory, vital signs and ECG recording;
  • Body mass index between ≥ 18.5 and ≤ 30.0 kg/m2;
  • Normal prostate-specific antigen (PSA) value (< 3.0 ng/mL);
  • Non-vasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study medication. Men who have been vasectomized less than 4 months prior to study start must follow the same restrictions as non-vasectomized men;
  • Men must agree not to donate sperm from the first dose until 90 days after the last dose;
  • Ability to communicate well with the Investigator and to comply with the requirements of the entire study;
  • Willing to give informed consent in writing.

Exclusion Criteria:

  • Any clinically significant abnormality following review of medical history, laboratory results, physical examination and ECG at screening as judged by the Investigator;
  • Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of any of the study drugs;
  • Previous use of steroids within:

    • 8 weeks for oral preparations
    • 4 weeks for transdermal preparations
    • Any time for injections;
  • Contraindications for steroids or estetrol;
  • Prostate hyperplasia or micturition problems that suggest the presence of prostate hyperplasia;
  • Presence of an active acute or chronic infection, including syphilis, HIV or viral hepatitis B and/or C (or previously treated);
  • Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication before screening;
  • Hypersensitivity to the active substances or to any of the excipients of the investigational product or placebo therapy;
  • Use of probiotics (as present in dairy products, fortified foods etc.) during the 3 months before screening and during the clinical study;
  • Use of one or more of the following medications:

    • Antihypertensive drugs
    • Present use or use within 30 days before the start of the study drug of the following drugs: aprepitant, bosentan, armodafinil, phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, glucocorticoids, topiramate, felbamate, rifampicin, clobazamechinacea; vemurafenib, non-nucleoside reverse transcriptase inhibitors, griseofulvin, ketoconazole, and herbal remedies containing Hypericum perforatum
    • Any medication (including over-the-counter products) within 14 days before first dosing except for occasional non-steroidal anti-inflammatory drugs (NSAIDs; e.g. ibuprofen); paracetamol is not permitted
    • Use of antibiotics;
  • Administration of any other investigational drug within 3 months before first dosing;
  • Loss of more than 400 mL blood during the 3 months before screening, e.g. as a blood donor, or intention to donate blood in the 3 months after completing the study;
  • Subjects with a history of (within 12 months) alcohol or drug abuse or with a positive result at screening, for tests of:

    • alcohol intake
    • drug abuse;
  • Currently smoking or smoked within the last 6 months before screening.

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 ClinicalTrials.gov identifier (NCT number): NCT02718378


Locations
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Netherlands
QPS Netherlands BV
Groningen, Netherlands, 9713 AG
Sponsors and Collaborators
Pantarhei Oncology B.V.
Investigators
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Principal Investigator: Tjeert Mensinga, MD, PhD QPS Netherlands BV
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pantarhei Oncology B.V.
ClinicalTrials.gov Identifier: NCT02718378    
Other Study ID Numbers: PR3107
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Keywords provided by Pantarhei Oncology B.V.:
safety
pharmacokinetics
pharmacodynamics
randomized
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases