PremenopauseNCT00628121
Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer
A study testing Cetrorelix in people with Premenopause, run by Nippon Kayaku Co., Ltd. at 1 site in Japan.
Trial summary
GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been investigated in studies conducted using doses of 1, 3 and 5 mg. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenopause
- What is being tested?
- Cetrorelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2006to Feb 2007
- Phase
- Interventional
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- a BMI of 18 years old and <18 and 25 years old and >25
- menstrual cycles was within the range of 25~31 days
Who cannot join
- use of a drug (e.g., oral contraceptives, drugs for treatment of hyperprolactinemia, GnRH agonists, sex steroid hormones, psychoactive drugs, etc.)
- serious disease of the endocrine system, liver, kidney, heart, lung, digestive system, etc.
- a generalized drug allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Pharmacological Study of NS75A for Healthy Adult Women
GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been investigated in studies conducted using doses of 1, 3 and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent prolongation of the duration of LH suppression. However, there have been few reports of studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the present study, we investigated the effect of cetrorelix on LH surge when this drug was administered in single doses of 1, 2 and 3 mg.
Read the detailed description
To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying the start of the LH surge in comparison with the control menstrual cycle when saline was administered, and also examined the mode of disappearance of pulsatile LH secretion during the cetrorelix administration menstrual cycle.
- Conditions
- Premenopause
- Being tested
- Cetrorelix
- Keywords
- infertility, menstrual cycle, LH surge
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetrorelixDrug
Also called NS75A
1, 2 or 3mg, subcutaneouly dosed with single dose
| Study group | Role | What they receive |
|---|---|---|
| Cetrorelix 1 mg | Experimental | Not described Receives: Drug: Cetrorelix |
| Cetrorelix 2 mg | Experimental | Not described Receives: Drug: Cetrorelix |
| Cetrorelix 3 mg | Experimental | Not described Receives: Drug: Cetrorelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day of the LH surge
Measured: Saline administration menstrual cycle, cetrorelix administration menstrual cycle
Secondary outcomes (1)
Serum LH concentrations
Measured: Saline administration menstrual cycle, cetrorelix administration menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startApr 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PremenopauseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nippon Kayaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shionogi, AEterna Zentaris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628121
- Sponsor's protocol ID
- 9575A402
- Status last verified
- Feb 2008
- First submitted
- 25 Feb 2008
- Last updated
- 4 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacological Study of NS75A for Healthy Adult Women
- ClinicalTrials.gov ID
- NCT00628121
- Acronym / sponsor ID
- 9575A402
- Conditions
- Premenopause
- Keywords
- infertility, menstrual cycle, LH surge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Nippon Kayaku Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shionogi, AEterna Zentaris
- Study start
- Apr 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 4 Mar 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.
GnRH analogs are globally used for assisted reproduction in infertile patients. To date, in healthy female volunteers the pharmacokinetic and pharmacodynamic profiles of cetrorelix when administered in a single dose have been investigated in studies conducted using doses of 1, 3 and 5 mg. Studies performed in premenopausal female volunteers confirmed that cetrorelix rapidly suppresses luteinizing hormone (LH) and estradiol and shows dose-dependent prolongation of the duration of LH suppression. However, there have been few reports of studies of the relationship between the cetrorelix dosage and its effect on LH surge. In the present study, we investigated the effect of cetrorelix on LH surge when this drug was administered in single doses of 1, 2 and 3 mg.
Detailed description
To evaluate that effect on LH surge, we investigated the efficacy of cetrorelix in delaying the start of the LH surge in comparison with the control menstrual cycle when saline was administered, and also examined the mode of disappearance of pulsatile LH secretion during the cetrorelix administration menstrual cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cetrorelix 1 mg | Experimental | Drug: Cetrorelix |
| Cetrorelix 2 mg | Experimental | Drug: Cetrorelix |
| Cetrorelix 3 mg | Experimental | Drug: Cetrorelix |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- a BMI of 18 years old and <18 and 25 years old and >25
- menstrual cycles was within the range of 25~31 days
Key exclusion criteria (3 listed)
- use of a drug (e.g., oral contraceptives, drugs for treatment of hyperprolactinemia, GnRH agonists, sex steroid hormones, psychoactive drugs, etc.)
- serious disease of the endocrine system, liver, kidney, heart, lung, digestive system, etc.
- a generalized drug allergy
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 |
|---|---|---|
| CetrorelixAlso: NS75A1, 2 or 3mg, subcutaneouly dosed with single dose | Drug | Cetrorelix 1 mg, Cetrorelix 2 mg, Cetrorelix 3 mg |
Primary outcome
Day of the LH surge
Time frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle
1 secondary outcome
Serum LH concentrations
Time frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle
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 Mar 2008.
Related trials for Premenopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
RecruitingObservational study
The Immunobiological Mechanisms of Depression in Perimenopause
Perimenopause, Major Depressive Episode (MDE)
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetrorelix in people with Premenopause, run by Nippon Kayaku Co., Ltd. at 1 site in Japan.
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 2 inclusion and 3 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 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Day of the LH surge (time frame: Saline administration menstrual cycle, cetrorelix administration menstrual cycle). 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 Mar 2008.