InfertilityPhase 1NCT00647933

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

A Phase 1 study testing Org 36286 and Lyndiol® in people with Infertility, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females. Read more about this study

Who is it for?: Ages 18 to 38 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infertility
What is being tested?: Org 36286 and Lyndiol®
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Jun 2000to Dec 2000
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 38 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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;

Show all 13Show fewer

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.

About this study

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®.

The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.

Conditions: Infertility
Being tested: Org 36286, Lyndiol®
Keywords: Females, Corifollitropin alfa, Antibodies, Pharmacokinetics, Pharmacodynamics
Medical subject headings: Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Org 36286Drug
Also called Corifollitropin alfa
Subcutaneous Org 36286
Lyndiol®Drug
Also called 50 μg ethinylestradiol + 2.5 mg lynestrenol
Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.

Study groups in NCT00647933
Study group	Role	What they receive
Org 36286 15 μg + Lyndiol®	Experimental	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. Receives: Drug: Org 36286; Drug: Lyndiol®
Org 36286 30 μg + Lyndiol®	Experimental	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. Receives: Drug: Org 36286; Drug: Lyndiol®
Org 36286 60 μg + Lyndiol®	Experimental	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. Receives: Drug: Org 36286; Drug: Lyndiol®
Org 36286 120 μg + Lyndiol®	Experimental	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. Receives: Drug: Org 36286; Drug: Lyndiol®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax)
Measured: Days 2 - 35
Total number of follicles >= 5 mm per day
Measured: Days 2 - 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2000Dec 2000

First posted1 Apr 2008 (estimated)
Study startJun 2000
Primary completionDec 2000
Study completionDec 2000

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfertilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00647933
Sponsor's protocol ID: P07004
Other IDs: 38802
Status last verified: Feb 2022
First submitted: 27 Mar 2008
Last updated: 3 Feb 2022
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
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All Infertility trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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®.
ClinicalTrials.gov ID: NCT00647933
Acronym / sponsor ID: P07004
Conditions: Infertility
Keywords: Females, Corifollitropin alfa, Antibodies, Pharmacokinetics, Pharmacodynamics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jun 2000
Primary completion: Dec 2000 (actual)
Study completion: Dec 2000 (actual)
First posted: 1 Apr 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Org 36286 15 μg + Lyndiol®	Experimental	Drug: Org 36286, Drug: 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 30 μg + Lyndiol®	Experimental	Drug: Org 36286, Drug: 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 60 μg + Lyndiol®	Experimental	Drug: Org 36286, Drug: 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 120 μg + Lyndiol®	Experimental	Drug: Org 36286, Drug: 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.

Who may qualify

Ages: 18 to 38 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Org 36286Also: Corifollitropin alfaSubcutaneous Org 36286	Drug	Org 36286 120 μg + Lyndiol®, Org 36286 15 μg + Lyndiol®, Org 36286 30 μg + Lyndiol®, Org 36286 60 μg + Lyndiol®
Lyndiol®Also: 50 μg ethinylestradiol + 2.5 mg lynestrenolLyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks.	Drug	Org 36286 120 μg + Lyndiol®, Org 36286 15 μg + Lyndiol®, Org 36286 30 μg + Lyndiol®, Org 36286 60 μg + Lyndiol®

Primary outcome

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

2 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.

Related trials for Infertility

RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Org 36286 and Lyndiol® in people with Infertility, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum number of follicles >= 5 mm (nmax) (time frame: Days 2 - 35). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00647933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.