Ovarian FollicleNCT00565240
Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women
A study testing Marvelon, Nuvaring and Letrozole in people with Ovarian Follicle, run by University of Saskatchewan at 1 site in Canada.
Trial summary
We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles in the extant wave and cause synchronous re-emergence of a new follicular wave. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Follicle
- What is being tested?
- Marvelon, Nuvaring and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Sep 2009
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female volunteers of childbearing potential;
- are first time users of OC or have discontinued OC at least 2 months prior to study entry;
- age between 18 and 35 years old;
- normal body mass index (18-30);
- has signed consent form; and
- is in good health as confirmed by medical history, physical examination
Who cannot join
- a positive pregnancy test will automatically exclude the volunteer from participation in this study.
- any contraindication for oral contraception use;
- known hypersensitivity to Letrozole and co-administered medications;
- irregular menstrual cycles;
- ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);
- history of pituitary tumor;
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- HIV, HBV, HCV infection;
- vaginal infection;
- abnormal ECG;
- abnormal lab tests for blood profile, liver function and renal function;
- uncontrolled diabetes and blood pressure;
- pregnancy (suspected or diagnosed) or lactation;
- history or suspicion of drug or alcohol abuse;
- history of severe mental disorders;
- participation in an investigational drug trial within the 30 days prior to selection;
- exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions:
- history of, or actual, thrombophlebitis or thromboembolic disorders.
- history of, or actual, cerebrovascular disorders.
- history of, or actual, myocardial infarction or coronary artery disease.
- acute liver disease.
- history of, or actual, benign or malignant liver tumors.
- history of, or suspected, carcinoma of the breast.
- known, or suspected, estrogen-dependent neoplasia.
- undiagnosed abnormal vaginal bleeding.
- any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual field.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971
We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate that this will provide us with information to facilitate the development of a new method for ovarian synchronization; a safer, more effective ovulation induction therapy; a new method for emergency contraception; and a greater understanding of human folliculogenesis.
- Conditions
- Ovarian Follicle
- Being tested
- Marvelon, Nuvaring, Letrozole
- Keywords
- ovarian synchronization, folliculogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarvelonDrug
oral contraceptive
NuvaringDrug
contraceptive vaginal ring
LetrozoleDrug
Aromatase Inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Oral Contraceptive | Experimental | Not described Receives: Drug: Marvelon |
| Contraceptive Ring | Experimental | Not described Receives: Drug: Nuvaring |
| Aromatase Inhibitors | Experimental | Not described Receives: Drug: Letrozole |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern.
Measured: 24-28 days
Secondary outcomes (1)
To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian FollicleStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Roger A Pierson, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565240
- Sponsor's protocol ID
- WHIRL-07-59
- Status last verified
- Apr 2010
- First submitted
- 27 Nov 2007
- Last updated
- 22 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971
- ClinicalTrials.gov ID
- NCT00565240
- Acronym / sponsor ID
- WHIRL-07-59
- Conditions
- Ovarian Follicle
- Keywords
- ovarian synchronization, folliculogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 Nov 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.
We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate that this will provide us with information to facilitate the development of a new method for ovarian synchronization; a safer, more effective ovulation induction therapy; a new method for emergency contraception; and a greater understanding of human folliculogenesis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral Contraceptive | Experimental | Drug: Marvelon |
| Contraceptive Ring | Experimental | Drug: Nuvaring |
| Aromatase Inhibitors | Experimental | Drug: Letrozole |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- female volunteers of childbearing potential;
- are first time users of OC or have discontinued OC at least 2 months prior to study entry;
- age between 18 and 35 years old;
- normal body mass index (18-30);
- has signed consent form; and
Key exclusion criteria (25 listed)
- a positive pregnancy test will automatically exclude the volunteer from participation in this study.
- any contraindication for oral contraception use;
- known hypersensitivity to Letrozole and co-administered medications;
- irregular menstrual cycles;
- ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);
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 |
|---|---|---|
| Marvelonoral contraceptive | Drug | Oral Contraceptive |
| Nuvaringcontraceptive vaginal ring | Drug | Contraceptive Ring |
| LetrozoleAromatase Inhibitors | Drug | Aromatase Inhibitors |
Primary outcome
To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern.
Time frame: 24-28 days
1 secondary outcome
To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment.
Time frame: ongoing
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 22 Apr 2010.
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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.
Roger A Pierson principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marvelon, Nuvaring and Letrozole in people with Ovarian Follicle, run by University of Saskatchewan at 1 site in Canada.
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 25 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 22 Apr 2010. 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 Canada. 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?
To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern. (time frame: 24-28 days). 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 22 Apr 2010.