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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00647933
First received: March 27, 2008
Last updated: August 6, 2014
Last verified: August 2014
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286 [ Time Frame: Days 1 - 15 ] [ Designated as safety issue: No ]
  • Mean dose-normalized area under the curve (AUC) post single dose Org 36286 [ Time Frame: Days 1 - 15 ] [ Designated as safety issue: No ]
  • Mean total plasma clearance (CL) post single dose Org 36286 [ Time Frame: Days 1 - 15 ] [ Designated as safety issue: No ]
  • Number of participants with an adverse event (AE) [ Time Frame: Start of treatment up to day 28 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Total number of follicles >= 5 mm per day [ Time Frame: Days 2 - 35 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00647933     History of Changes
Other Study ID Numbers: P07004, 38802
Study First Received: March 27, 2008
Last Updated: August 6, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Lynestrenol
Noracycline
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on October 19, 2014