An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)
NCT ID: NCT00647933
Last Updated: 2022-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2000-06-30
2000-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Org 36286
Subcutaneous Org 36286
Lyndiol®
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
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.
Org 36286
Subcutaneous Org 36286
Lyndiol®
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
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.
Org 36286
Subcutaneous Org 36286
Lyndiol®
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
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.
Org 36286
Subcutaneous Org 36286
Lyndiol®
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
Interventions
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Org 36286
Subcutaneous Org 36286
Lyndiol®
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index between 18 and 29 kg/m\^2;
* Good venous accessibility;
Exclusion Criteria
* 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.
18 Years
38 Years
FEMALE
Yes
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Other Identifiers
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38802
Identifier Type: -
Identifier Source: secondary_id
P07004
Identifier Type: -
Identifier Source: org_study_id
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