AnovulationPhase 2NCT00213148
Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
A Phase 2 study testing Anastrozole 1 mg, Anastrozole 5 mg and Anastrozole 10 mg in people with Anovulation, run by EMD Serono at 1 site in United States.
Trial summary
The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anovulation
- What is being tested?
- Anastrozole 1 mg, Anastrozole 5 mg and Anastrozole 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2005to 12 Dec 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-40 years
- Ovulatory dysfunction characterized by irregular and/or extended cycles
- Non-smoker
Who cannot join
- No previous gonadotropin treatment
- No more than 6 previous clomiphene treatment cycles
Trial locations and contacts
1 site in 1 country.
United States1 site
Local US Medical Information
Rockland, Massachusetts, 02370
About this study
Official title: A Phase II, Prospective, Randomized, Double-Blind, Multicenter, Dose Finding, Comparative Study for the Evaluation of the Aromatase Inhibitor Anastrozole (Multiple-Dose) Versus Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.
- Conditions
- Anovulation
- Being tested
- Anastrozole 1 mg, Anastrozole 5 mg, Anastrozole 10 mg, Clomiphene Citrate 50 mg, Clomiphene Citrate 100 mg
- Medical subject headings
- Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anastrozole 1 mgDrug
Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
Anastrozole 5 mgDrug
Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
Anastrozole 10 mgDrug
Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
Clomiphene Citrate 50 mgDrug
Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month).
Clomiphene Citrate 100 mgDrug
Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene Citrate 50 Milligram (mg) | Active comparator | Not described Receives: Drug: Clomiphene Citrate 50 mg |
| Clomiphene Citrate 100 mg | Active comparator | Not described Receives: Drug: Clomiphene Citrate 100 mg |
| Anastrozole 1 mg | Experimental | Not described Receives: Drug: Anastrozole 1 mg |
| Anastrozole 5 mg | Experimental | Not described Receives: Drug: Anastrozole 5 mg |
| Anastrozole 10 mg | Experimental | Not described Receives: Drug: Anastrozole 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Rate in Cycle 1
Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron [P4] level greater than or equal to [>=] 10 nanogram per milliliter [ng/mL] and/or pregnancy).
Measured: Up to 1 month
Secondary outcomes (1)
Number of Subjects With Clinical Pregnancy in Cycle 1
Clinical pregnancy was defined as the existence of at least one ultrasonographically confirmed gestational sac in the uterus with fetal heart activity.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study start10 Mar 2005
- Primary completion12 Dec 2007
- Study completion12 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213148
- Sponsor's protocol ID
- 25550
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2005
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Randomized, Double-Blind, Multicenter, Dose Finding, Comparative Study for the Evaluation of the Aromatase Inhibitor Anastrozole (Multiple-Dose) Versus Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
- ClinicalTrials.gov ID
- NCT00213148
- Acronym / sponsor ID
- 25550
- Conditions
- Anovulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2005 (actual)
- Primary completion
- 12 Dec 2007 (actual)
- Study completion
- 12 Dec 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Clomiphene Citrate 50 Milligram (mg) | Active comparator | Drug: Clomiphene Citrate 50 mg |
| Clomiphene Citrate 100 mg | Active comparator | Drug: Clomiphene Citrate 100 mg |
| Anastrozole 1 mg | Experimental | Drug: Anastrozole 1 mg |
| Anastrozole 5 mg | Experimental | Drug: Anastrozole 5 mg |
| Anastrozole 10 mg | Experimental | Drug: Anastrozole 10 mg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-40 years
- Ovulatory dysfunction characterized by irregular and/or extended cycles
- Non-smoker
Key exclusion criteria (2 listed)
- No previous gonadotropin treatment
- No more than 6 previous clomiphene treatment cycles
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 |
|---|---|---|
| Anastrozole 1 mgSubjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). | Drug | Anastrozole 1 mg |
| Anastrozole 5 mgSubjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). | Drug | Anastrozole 5 mg |
| Anastrozole 10 mgSubjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). | Drug | Anastrozole 10 mg |
| Clomiphene Citrate 50 mgSubjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). | Drug | Clomiphene Citrate 50 Milligram (mg) |
| Clomiphene Citrate 100 mgSubjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month). | Drug | Clomiphene Citrate 100 mg |
Primary outcome
Ovulation Rate in Cycle 1
Time frame: Up to 1 month
Ovulation rate was defined as the percentage of subjects who ovulated (mid-luteal Progesteron [P4] level greater than or equal to [>=] 10 nanogram per milliliter [ng/mL] and/or pregnancy).
1 secondary outcome
Number of Subjects With Clinical Pregnancy in Cycle 1
Time frame: Up to 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Medical Responsible study director
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anastrozole 1 mg, Anastrozole 5 mg and Anastrozole 10 mg in people with Anovulation, run by EMD Serono at 1 site in United States.
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 2 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 17 Jul 2018. 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 United States. 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.
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?
Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ovulation Rate in Cycle 1 (time frame: Up to 1 month). 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 17 Jul 2018.