AnovulationNCT00920634
Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)
An observational study of Anovulation, run by Organon and Co.
Trial summary
The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anovulation
- What is being tested?
- Follitropin beta
- Type of treatment
- Injection or infusion
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Mar 2009
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese 300 patients
Who may be able to join
- Patients who underwent IVF
Who cannot join
- Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
- Pregnant or possible pregnant women, or lactating women
- Patients with undiagnosed atypical vaginal bleeding
- Patients with a history of hypersensitivity to any of the ingredients of this product
- Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease
About this study
Official title: Protocol for Drug Use Investigation of Follistim Injection
The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Conditions
- Anovulation
- Being tested
- Follitropin beta
- Medical subject headings
- Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin betaDrug
For subcutaneous or intramuscular injection, the usual dosage is 50 IU of follitropin beta (recombinant) once daily for 7 days. The dosage should be adjusted subsequently while monitoring the development of follicles (dose increase by 25 IU every 7 days if the response of the ovaries is poor) and, after confirming presence of follicles of 18 mm or larger in mean diameter by the ultrasonic tomography, ovulation is induced by the administration of a human chorionic gonadotropin preparation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction Receives: Drug: Follitropin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of ovulation
Measured: 3 months, from initiation of treatment to confirmation of pregnancy.
Secondary outcomes (1)
Pregnancy outcome
Measured: 3 months, from initiation of treatment to confirmation of pregnancy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnovulationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920634
- Sponsor's protocol ID
- P06132
- Status last verified
- Feb 2022
- First submitted
- 12 Jun 2009
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Drug Use Investigation of Follistim Injection
- ClinicalTrials.gov ID
- NCT00920634
- Acronym / sponsor ID
- P06132
- Conditions
- Anovulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Jun 2009 (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 main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Follitropin betaPatients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese 300 patients
Key inclusion criteria (1 listed)
- Patients who underwent IVF
Key exclusion criteria (5 listed)
- Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
- Pregnant or possible pregnant women, or lactating women
- Patients with undiagnosed atypical vaginal bleeding
- Patients with a history of hypersensitivity to any of the ingredients of this product
- Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease
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 |
|---|---|---|
| Follitropin betaFor subcutaneous or intramuscular injection, the usual dosage is 50 IU of follitropin beta (recombinant) once daily for 7 days. The dosage should be adjusted subsequently while monitoring the development of follicles (dose increase by 25 IU every 7 days if the response of the ovaries is poor) and, after confirming presence of follicles of 18 mm or larger in mean diameter by the ultrasonic tomography, ovulation is induced by the administration of a human chorionic gonadotropin preparation. | Drug | 1 |
Primary outcome
Occurrence of ovulation
Time frame: 3 months, from initiation of treatment to confirmation of pregnancy.
1 secondary outcome
Pregnancy outcome
Time frame: 3 months, from initiation of treatment to confirmation of pregnancy.
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 4 Feb 2022.
Related trials for Anovulation
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingObservational study
Half-dose vs Conventional-dose Cetrorelix in ICSI Cycles
Infertility, Infertility, Female
Recruiting
Sperm Preparation Prior to Intrauterine Insemination Study
Infertility, Infertility Secondary
Not yet recruiting
Ovarian Stromal Stiffness and Ovarian Reserve Parameters Via Transvaginal Shear Wave Elastography
Ovarian Reserve Markers, Ovarian Function
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?
An observational study of Anovulation, 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 1 inclusion and 5 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 4 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.
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?
Occurrence of ovulation (time frame: 3 months, from initiation of treatment to confirmation of pregnancy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2022.