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An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00647933
First Posted: April 1, 2008
Last Update Posted: June 29, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.

Condition Intervention Phase
Infertility Drug: Org 36286 Drug: Lyndiol® Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 After a Single Subcutaneous Dose in Healthy Female Volunteers Whose Pituitary Function is Suppressed by Lyndiol®.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Maximum number of follicles >= 5 mm (nmax) [ Time Frame: Days 2 - 35 ]
  • Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286 [ Time Frame: Days 1 - 15 ]
  • Mean dose-normalized area under the curve (AUC) post single dose Org 36286 [ Time Frame: Days 1 - 15 ]
  • Mean total plasma clearance (CL) post single dose Org 36286 [ Time Frame: Days 1 - 15 ]
  • Number of participants with an adverse event (AE) [ Time Frame: Start of treatment up to day 28 ]

Secondary Outcome Measures:
  • Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax) [ Time Frame: Days 2 - 35 ]
  • Total number of follicles >= 5 mm per day [ Time Frame: Days 2 - 35 ]

Enrollment: 24
Study Start Date: June 2000
Study Completion Date: December 2000
Primary Completion Date: December 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Org 36286 15 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 15 μg.
Drug: Org 36286
Subcutaneous Org 36286
Other Name: Corifollitropin alfa
Drug: Lyndiol®
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
Other Name: 50 μg ethinylestradiol + 2.5 mg lynestrenol
Experimental: Org 36286 30 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 30 μg.
Drug: Org 36286
Subcutaneous Org 36286
Other Name: Corifollitropin alfa
Drug: Lyndiol®
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
Other Name: 50 μg ethinylestradiol + 2.5 mg lynestrenol
Experimental: Org 36286 60 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 60 μg.
Drug: Org 36286
Subcutaneous Org 36286
Other Name: Corifollitropin alfa
Drug: Lyndiol®
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
Other Name: 50 μg ethinylestradiol + 2.5 mg lynestrenol
Experimental: Org 36286 120 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 120 μg.
Drug: Org 36286
Subcutaneous Org 36286
Other Name: Corifollitropin alfa
Drug: Lyndiol®
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
Other Name: 50 μg ethinylestradiol + 2.5 mg lynestrenol

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good physical and mental health;
  • Body Mass Index between 18 and 29 kg/m^2;
  • Good venous accessibility;

Exclusion Criteria:

  • Clinically relevant abnormal blood chemistry, hematology and/or urinalysis at screening;
  • Hypertension (sitting diastolic blood pressure > 90 mmHg and/or systolic blood pressure > 150 mmHg);
  • Contraindications for the use of oral contraceptives or gonadotropins;
  • PAP-smear (= III) according to the Papanicolaou classification;
  • History of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or any evidence of ovarian dysfunction;
  • Primary ovarian failure;
  • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease;
  • Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation;
  • Ovarian surgery;
  • Smoking more than 10 cigarettes or equivalents a day;
  • History (within 12 months) of alcohol or drugs abuse;
  • Blood donation (> 200 ml) within 90 days prior to screening;
  • Administration of investigational drugs within 90 days prior to start Org 36286.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00647933     History of Changes
Other Study ID Numbers: P07004
38802
First Submitted: March 27, 2008
First Posted: April 1, 2008
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Females
Corifollitropin alfa
Antibodies
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Ethinyl Estradiol
Mestranol
Noracycline
Lynestrenol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic