InfertilityPhase 2NCT00702585

Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)

A Phase 2 study testing Org 36286 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 trial were to investigate the feasibility and the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility and to assess the safety (including the absence of antibody formation) of Org 36286. Read more about this study

Who is it for?: Ages 18 to 39 years, women only
Conditions the study is for: Infertility
What is being tested?: Org 36286
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: No sites listed yet
Study dates: 1 Aug 2001to 15 Oct 2002
Phase: Phase 2
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 39 years
Women only
No healthy volunteers
Adult

Who may be able to join

Wish to conceive;
Oligomenorrhea (cycle length >=41 days) or amenorrhea (no menstrual cycle for >6 months);
Body Mass Index (BMI) >=18 and <=32 kg/m^2;
Serum FSH levels within normal limits (1-10 IU/L);
Normal serum prolactin and thyroid stimulating hormone (TSH) levels;
Progestagen induced withdrawal bleeding or spontaneous menstrual bleeding;

Who cannot join

Tumours of the ovary, breast, uterus, pituitary or hypothalamus;
Pregnancy or lactation;
Undiagnosed vaginal bleeding;
Ovarian cysts or enlarged ovaries not related to polycystic ovarian disease (PCOD);
Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
Malformations of the sexual organs incompatible with pregnancy;

Show all 14Show fewer

Clomiphene resistance with documented anovulation (treated with 150 mg clomiphene for five days and no ovulation);
Treatment with metformin, gonadotropins, or GnRH analogs within 90 days prior to the start of Org 36286 treatment;
Treatment with clomiphene citrate within 42 days prior to the start of Org 36286 treatment;
Alcohol or drug abuse within the 12 months preceding signing of informed consent;
Any clinically relevant abnormal laboratory value;
Hypersensitivity to any of the substances in Org 36286;
Hypersensitivity to Orgalutran® or any of its components;
Use of any investigational drugs during 90 days before screening or previous participation in this trial.

About this study

Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Comparative Trial to Investigate the Optimal Dose of a Single Administration of Org 36286 (Corifollitropin Alfa) to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility

Read the detailed description

This was a phase II, randomized, double-blind, placebo controlled, comparative trial to investigate the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility.

Treatment injection was given on Day 1-3 after the onset of a spontaneous or progestagen induced withdrawal bleeding. After injection, ultrasound monitoring and sampling for serum hormones were done on treatment Days 3, 5, and daily from Day 7 to 21 or until a urinary luteinizing hormone (LH) peak was detected. From treatment Day 7 the urinary LH response was assessed to detect the preovulatory LH peak. In case of hyperstimulation, production of endogenous gonadotropins could be suppressed by giving daily injections of GnRH antagonist.

Post-treatment assessments were done in the third week after the urinary LH peak. If no LH peak was detected, posttreatment assessments were performed four to five weeks after Org 36286 or placebo injection.

Conditions: Infertility
Being tested: Org 36286, Placebo
Keywords: Ovulation Induction, Pharmacological effects of drugs, Hormones, Hormone substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national
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 alpha
Org 36286 single-dose subcutaneous injection
PlaceboDrug
Placebo to Org 36286 as a single-dose subcutaneous injection

Study groups in NCT00702585
Study group	Role	What they receive
Org 36286 7.5 µg	Experimental	Org 36286 7.5 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. Receives: Drug: Org 36286
Org 36286 15 µg	Experimental	Org 36286 15 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. Receives: Drug: Org 36286
Org 36286 30 µg	Experimental	Org 36286 30 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. Receives: Drug: Org 36286
Org 36286 60 µg	Experimental	Org 36286 60 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. Receives: Drug: Org 36286
Placebo	Placebo comparator	Placebo to Org 36286 administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. Receives: Drug: Placebo

What is being measured

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

Participant Ovulation Rate in Monofollicular Cycles
Measured: Up to 2 Weeks Following LH Peak

Secondary outcomes (12)

Participant Overall Ovulation Rate
Measured: Up to 2 Weeks Following LH Pek
Number of Participants With Cancellation of Menstrual Cycle
Measured: Up to Day 21
Participant Follicle Size
Measured: Up to Day 21
Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies
Measured: Up to 10 Weeks Following Ovulation
Number of Participants Experiencing Serious Adverse Events (SAEs)
Measured: Up to 10 Weeks Following Ovulation
Number of Participants With Clinically Significant Laboratory Abnormalities
Measured: Up to 3 Weeks Following Ovulation
Number of Participants With Clinically Significant Changes in Vital Signs
Measured: Up to 3 Weeks Followiing Ovulation
Number of Participants With Antibodies to Org 36286
Measured: Up to 3 Weeks Following Ovulation
Participant Serum Follicle Stimulating Hormone (FSH) Level
Measured: Up to Day 21
Participant Serum LH Level
Measured: Up to Day 21
Participant Inhibin-B, E2, and P Serum Concentration
Measured: Up to Day 21
Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS)
Measured: Up to 2 Weeks Following LH Peak

Timeline

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

1 Aug 200115 Oct 2002

First posted20 Jun 2008 (estimated)
Study start1 Aug 2001
Primary completion15 Oct 2002
Study completion15 Oct 2002

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00702585
Sponsor's protocol ID: P07016
Other IDs: 38805
Status last verified: Feb 2022
First submitted: 18 Jun 2008
Last updated: 15 Aug 2024
Results posted: No
Data monitoring committee: Yes

Publications

Balen AH, Mulders AG, Fauser BC, Schoot BC, Renier MA, Devroey P, Struijs MJ, Mannaerts BM. Pharmacodynamics of a single low dose of long-acting recombinant follicle-stimulating hormone (FSH-carboxy terminal peptide, corifollitropin alfa) in women with World Health Organization group II anovulatory infertility. J Clin Endocrinol Metab. 2004 Dec;89(12):6297-304. doi: 10.1210/jc.2004-0668.
PubMed 15579793

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

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Comparative Trial to Investigate the Optimal Dose of a Single Administration of Org 36286 (Corifollitropin Alfa) to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility
ClinicalTrials.gov ID: NCT00702585
Acronym / sponsor ID: P07016
Conditions: Infertility
Keywords: Ovulation Induction, Pharmacological effects of drugs, Hormones, Hormone substitutes and Hormone Antagonists, Pharmacological Actions, Randomized, Multi-center, Multi-national
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 1 Aug 2001 (actual)
Primary completion: 15 Oct 2002 (actual)
Study completion: 15 Oct 2002 (actual)
First posted: 20 Jun 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Org 36286 7.5 µg	Experimental	Drug: Org 36286Org 36286 7.5 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Org 36286 15 µg	Experimental	Drug: Org 36286Org 36286 15 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Org 36286 30 µg	Experimental	Drug: Org 36286Org 36286 30 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Org 36286 60 µg	Experimental	Drug: Org 36286Org 36286 60 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.
Placebo	Placebo comparator	Drug: PlaceboPlacebo to Org 36286 administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later.

Who may qualify

Ages: 18 to 39 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Wish to conceive;
Oligomenorrhea (cycle length >=41 days) or amenorrhea (no menstrual cycle for >6 months);
Body Mass Index (BMI) >=18 and <=32 kg/m^2;
Serum FSH levels within normal limits (1-10 IU/L);
Normal serum prolactin and thyroid stimulating hormone (TSH) levels;

Key exclusion criteria (14 listed)

Tumours of the ovary, breast, uterus, pituitary or hypothalamus;
Pregnancy or lactation;
Undiagnosed vaginal bleeding;
Ovarian cysts or enlarged ovaries not related to polycystic ovarian disease (PCOD);
Any ovarian and/or abdominal abnormality interfering with ultrasound examination;

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 alphaOrg 36286 single-dose subcutaneous injection	Drug	Org 36286 15 µg, Org 36286 30 µg, Org 36286 60 µg, Org 36286 7.5 µg
PlaceboPlacebo to Org 36286 as a single-dose subcutaneous injection	Drug	Placebo

Primary outcome

Participant Ovulation Rate in Monofollicular Cycles
Time frame: Up to 2 Weeks Following LH Peak

12 secondary outcomes

Participant Overall Ovulation Rate
Time frame: Up to 2 Weeks Following LH Pek
Number of Participants With Cancellation of Menstrual Cycle
Time frame: Up to Day 21
Participant Follicle Size
Time frame: Up to Day 21
Number of Participants With Miscarriages, Biochemical, Ectopic, Clinical, Vital, Single, or Multiple Ongoing Pregnancies
Time frame: Up to 10 Weeks Following Ovulation
Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 10 Weeks Following Ovulation
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Up to 3 Weeks Following Ovulation
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to 3 Weeks Followiing Ovulation
Number of Participants With Antibodies to Org 36286
Time frame: Up to 3 Weeks Following Ovulation
Participant Serum Follicle Stimulating Hormone (FSH) Level
Time frame: Up to Day 21
Participant Serum LH Level
Time frame: Up to Day 21
Participant Inhibin-B, E2, and P Serum Concentration
Time frame: Up to Day 21
Number of Participants with Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: Up to 2 Weeks Following LH Peak

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 15 Aug 2024.
Results publication: PubMed 15579793Balen AH, Mulders AG, Fauser BC, Schoot BC, Renier MA, Devroey P, Struijs MJ, Mannaerts BM. Pharmacodynamics of a single low dose of long-acting recombinant follicle-stimulating hormone (FSH-carboxy terminal peptide, corifollitropin alfa) in women with World Health Organization group II anovulatory infertility. J Clin Endocrinol Metab. 2004 Dec;89(12):6297-304. doi: 10.1210/jc.2004-0668.

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
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RecruitingObservational study
Pilot Study of Discarded Blastocysts
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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 2 study testing Org 36286 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 6 inclusion and 14 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 15 Aug 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Participant Ovulation Rate in Monofollicular Cycles (time frame: Up to 2 Weeks Following LH Peak). 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 NCT00702585, which also lists 1 linked publication.

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 15 Aug 2024.