Menstruation DisordersPhase 2NCT00467493
Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers
A Phase 2 study testing Anastrozole in people with Menstruation Disorders, run by Meditrina Pharmaceuticals at 2 sites in United States.
Trial summary
Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation Disorders
- What is being tested?
- Anastrozole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Sep 2007
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 25 and 45 and pre-menopausal;
- Non-lactating and not pregnant
- able to follow the schedule of procedures
- able to freely provide informed consent
- have clinically acceptable physical examination and safety laboratory studies
Who cannot join
- current use of any form of systemic contraceptive
- have self-reported irregular menstrual cycles
- intercurrent illness(es) detected on the screening physical
- unwilling or unable to use barrier methods of contraception
- have evidence of endometrial polyps or myomata on TVU/SIS that would interfere with endometrial thickness measurement
- detection of ovarian cyst(s) during adnexal examination on screening TVU/SIS measuring greater than 5 cm
Show all 16Show fewer
- have history of, or current cancer, on any form exclusive of basal cell carcinoma
- BMI >= 35
- history of alcohol or drug abuse in the past 5 years
- unwilling or unable to undergo study procedures within the necessary time frames
- history or current liver abnormalities as defined by ALT or AST > 2X ULN
- treated or untreated diabetes defined as fasting blood sugar >= 126 mg/dL
- untreated hypertension
- impaired renal function by estimated creatinine clearance < 80mL/min
- have estradiol levels < 20 pg/ml and FSH levels > 40 mIU/mL or
- have a history of adverse reaction any aromatase inhibitor
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jasper Research Clinic
Kalamazoo, Michigan, 49007
University Women's Care
Southfield, Michigan, 48034
About this study
Official title: A Partial Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Anastrozole, an Aromatase Inhibitor, on Endometrial Thickness in Healthy Premenopausal Women When Dosed at Various Times During the Menstrual Cycle (Protocol M-001)
Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol. This class of drugs, aromatase inhibitors, are very effective in reducing estradiol levels in postmenopausal women and in treating estrogen receptor positive breast cancers. This study is examining the effect of a specific inhibitor, anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial thickness. The main hypothesis is that anastrozole can be administered at any time during the menstrual cycle and reduce endometrial thickness compared to placebo.
- Conditions
- Menstruation Disorders
- Being tested
- Anastrozole
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Anastrozole - A | Experimental | Treatment for 26 consecutive days Receives: Drug: Anastrozole |
| Anastrozole -B | Experimental | Treatment for 7 consecutive days early in menstrual cycle Receives: Drug: Anastrozole |
| Anastrozoe - C | Experimental | Treatment for 7 consecutive days mid follicular phase Receives: Drug: Anastrozole |
| Anastrozole - D | Experimental | Treatment for 7 consecutive days - mid cycle Receives: Drug: Anastrozole |
| Anastrozole - E | Experimental | Treatment for 7 consecutive days - luteal Receives: Drug: Anastrozole |
| Anastrozole - F | Placebo comparator | Treatment with placebo for 26 consecutive days Receives: Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness as measured by transvaginal ultrasound, safety
Measured: Over one menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstruation DisordersStudies 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
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meditrina Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467493
- Sponsor's protocol ID
- M-001
- Status last verified
- Jun 2009
- First submitted
- 27 Apr 2007
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partial Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Anastrozole, an Aromatase Inhibitor, on Endometrial Thickness in Healthy Premenopausal Women When Dosed at Various Times During the Menstrual Cycle (Protocol M-001)
- ClinicalTrials.gov ID
- NCT00467493
- Acronym / sponsor ID
- M-001
- Conditions
- Menstruation Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Meditrina PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 30 Apr 2007 (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.
Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol. This class of drugs, aromatase inhibitors, are very effective in reducing estradiol levels in postmenopausal women and in treating estrogen receptor positive breast cancers. This study is examining the effect of a specific inhibitor, anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial thickness. The main hypothesis is that anastrozole can be administered at any time during the menstrual cycle and reduce endometrial thickness compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Anastrozole - A | Experimental | Drug: AnastrozoleTreatment for 26 consecutive days |
| Anastrozole -B | Experimental | Drug: AnastrozoleTreatment for 7 consecutive days early in menstrual cycle |
| Anastrozoe - C | Experimental | Drug: AnastrozoleTreatment for 7 consecutive days mid follicular phase |
| Anastrozole - D | Experimental | Drug: AnastrozoleTreatment for 7 consecutive days - mid cycle |
| Anastrozole - E | Experimental | Drug: AnastrozoleTreatment for 7 consecutive days - luteal |
| Anastrozole - F | Placebo comparator | Drug: AnastrozoleTreatment with placebo for 26 consecutive days |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 25 and 45 and pre-menopausal;
- Non-lactating and not pregnant
- able to follow the schedule of procedures
- able to freely provide informed consent
- have clinically acceptable physical examination and safety laboratory studies
Key exclusion criteria (16 listed)
- current use of any form of systemic contraceptive
- have self-reported irregular menstrual cycles
- intercurrent illness(es) detected on the screening physical
- unwilling or unable to use barrier methods of contraception
- have evidence of endometrial polyps or myomata on TVU/SIS that would interfere with endometrial thickness measurement
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 | Drug | Anastrozoe - C, Anastrozole - A, Anastrozole - D, Anastrozole - E, Anastrozole - F, Anastrozole -B |
Primary outcome
Endometrial thickness as measured by transvaginal ultrasound, safety
Time frame: Over one 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 3 Jun 2009.
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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.
2 sites 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 in people with Menstruation Disorders, run by Meditrina Pharmaceuticals at 2 sites 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 5 inclusion and 16 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 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Endometrial thickness as measured by transvaginal ultrasound, safety (time frame: Over one 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 3 Jun 2009.