FertilityPhase 4NCT01046578
Aromatase Inhibitor Effects on Ovarian Function During the Follicular and Early Luteal Phase in Women
A Phase 4 study testing Letrozole in people with Fertility, run by University of Saskatchewan at 1 site in Canada.
Trial summary
A single center, open label randomized clinical trial designed to examine ovarian follicular dynamics following attempted atresia induction during the late follicular and early luteal phase of the menstrual cycle using an aromatase inhibitor. 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
- Fertility
- What is being tested?
- 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
- Jan 2010to Feb 2012
- Phase
- Phase 4
- 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 subjects of childbearing potential with normal reproductive function;
- Women between 18 and 35 years of age;
- Normal Body Mass Index (18-30);
- Are naïve to OC or have discontinued OC at least 2 months prior to study entry;
- Subject has signed the informed consent form;
- Subject is in good general health as confirmed by medical history and physical examination
Who cannot join
- Irregular menstrual cycles;
- Any contraindication for oral contraception use;
- Known hypersensitivity to Letrozole and co-administered medications;
- Evidence of Polycystic Ovary Syndrome (PCOS) or Endometriosis;
- History of pituitary tumor;
- Pregnancy (suspected or diagnosed) or lactation;
Show all 24Show fewer
- HIV, HBV, HCV infection;
- Vaginal infection;
- Abnormal ECG;
- Abnormal lab tests for blood profile, liver function and renal function;
- Uncontrolled diabetes and blood pressure;
- History or suspicion of alcohol or drug abuse;
- History of severe mental disorders;
- Participation in an investigational drug trial in the 30 days prior to selection;
- A subject who 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 arterial disease.
- Active liver disease or history of/or actual benign or malignant liver tumors.
- Known or suspected carcinoma of the breast.
- Known or suspected oestrogen-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 fields.
- Smokes.
Trial locations and contacts
1 site in 1 country.
About this study
A single center, open label randomized clinical trial designed to examine ovarian follicular dynamics following attempted atresia induction during the late follicular and early luteal phase of the menstrual cycle using an aromatase inhibitor.
We hypothesize that administration of an aromatase inhibitor (AI) at biologically important times of the natural menstrual cycle will cause ovulatory failure in women with preovulatory follicles and failure of luteogenesis in women who have recently ovulated. It is proposed that atresia of the dominant follicle and formation of anovulatory structures will be associated with arrested endometrial development and a shortened interval to menstrual bleeding (3 days). We anticipate that this will provide us with information to facilitate the development of a new method for emergency contraception and a greater understanding of human folliculogenesis.
The rationale for the proposed research project is based on the ovarian synchronization concepts developed and documented in the bovine model in the Reproductive Science and Medicine Research group at the University of Saskatchewan combined with novel human ovarian wave concepts of folliculogenesis first elucidated in the Women's Health Imaging Research Laboratory (WHIRL) in the Department of Obstetrics, Gynecology and Reproductive Sciences.
Read the detailed description
In clinical practice emergency contraception (EC) intends to suppress follicular development, ovulation, or the ability of a conceptus to implant. Exogenous steroids, estrogen and progestin, are used in various formulations to accomplish the suppression. Though EC are now available 'over-the-counter' in Canada and many countries around the world; the ovarian response is unpredictable and EC do not inhibit ovulation at the most critical times of the menstrual cycle. In 2002 approximately 120,000 of 450,000 pregnancies in Canada ended in elective pregnancy termination. In the US 49% of the 3.5 million annual pregnancies were unintended and 54% of the unintended pregnancies resulted in elective termination.
Current hormonal contraceptive regimens, pre and post coital, are based on the traditional theory of follicular development that states that a single group of antral follicles is recruited in the late luteal phase for growth. Recent documentation has show that human ovarian folliculogenesis occurs in a 2-3 wave like pattern during a menstrual cycle. Wave emergence has been documented to occur in the early luteal phase with the final wave being ovulatory. The new model of follicular wave dynamics is well established and supported by experimental evidence in the bovine and equine models.
Traditionally these hormonal medications are taken 72 to 120 hours after known or suspected barrier contraception failure or unprotected intercourse. The two standard steroidal EC methods are Plan BTM, containing of 0.75 mg levonorgestrel (LNG), and the Yuzpe method, containing 0.1 mg ethinyl estradiol (EE) and 0.5 mg LNG. Ovarian follicular development and ovulation in women have been studied after EC use; however, the mechanisms underlying follicular growth, regression, and ovulation during EC use remain poorly elucidated. The mechanism of action differs with each EC regimen as well as being dependent upon the relative timing between dosing, intercourse, and ovulation. Previous studies have shown that EC are most effective if used when the dominant follicle diameter is small (4 to 5 days prior to ovulation), however, during this time interval intercourse is less likely to result in pregnancy whether or not EC were administered.
All current emergency contraception (EC) options are guided by the traditional theory of follicular development. Based on the findings of an unpredictable response of the ovaries to EC treatment, the occurrence of ovulation after treatment with EC, and findings of follicle growth in a 2-3 wave pattern, we need to reconsider the phase of the menstrual cycle and the treatment given for emergency contraception.
Aromatase inhibitors (AI) prevent the enzymatic conversion of androgens to estrogens. This significantly lowers serum estrogen levels. AI have been administered around the time of menses for ovulation induction and ovulation was seen to follow 10 to 12 days later. The rationale for inducing atresia of dominant follicles stems from this observation. Acute estradiol deprivation should theoretically initiate atresia of all viable follicles in the cohort resulting in the emergence of a new follicle wave without an ovulation event occurring.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara (TM)
20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 12 mm in diameter
LetrozoleDrug
Also called Femara (TM)
20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 18 mm in diameter
LetrozoleDrug
Also called Femara (TM)
20 mg, one tablet a day for one day, starting 24-48 hours after ovulation of the dominant follicle is observed
LetrozoleDrug
Also called Femara (TM)
2.5 mg, one tablet a day for five days, starting 24-48 hours after ovulation of the dominant follicle is observed
LetrozoleDrug
Also called Femara (TM)
2.5 mg, one tablet a day for five days, starting on the day the dominant follicle reaches 18 mm in diameter
LetrozoleDrug
Also called Femara (TM)
2.5 mg, one tablet a day for five days, starting on the day the dominant follicle reaches 18 mm in diameter
| Study group | Role | What they receive |
|---|---|---|
| Single Dose 12mm follicle | Experimental | Single dose (20mg) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 12 mm Receives: Drug: Letrozole |
| Single Dose 18mm follicle | Experimental | Single dose (20mg) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 18 mm Receives: Drug: Letrozole |
| Single Dose Post Ovulation | Experimental | Single dose (20mg) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated 24-48 post ovulation Receives: Drug: Letrozole |
| Multi Dose 12mm follicle | Experimental | Multi dose (2.5mg/day for 5 days) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 12 mm Receives: Drug: Letrozole |
| Multi Dose 18mm follicle | Experimental | Multi dose (2.5mg/day for 5 days) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 18 mm Receives: Drug: Letrozole |
| Multi Dose Post Ovulation | Experimental | Multi dose (2.5mg/day for 5 days) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated 24-48 hours post ovulation Receives: Drug: Letrozole |
| Control | No intervention | No intervention given, followed for course of study on a natural cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
fate of the dominant follicle or luteal structure
Measured: 40-45 days
Secondary outcomes (3)
interval to follicle wave emergence, and interval to selection of a dominant follicle
Measured: 40-45 days
endometrial thickness/pattern
Measured: 40-45 days
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 posted12 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies 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 4
- Primary purpose
- Basic science
- 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)
- Responsible party
- Principal investigator, Roger Pierson, University of Saskatchewan
- Investigators
- Roger A Pierson, PhD, Principal investigator, University of SaskatchewanDonna R Chizen, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046578
- Sponsor's protocol ID
- WHIRL-08-1200
- Status last verified
- Nov 2016
- First submitted
- 8 Jan 2010
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Allaway HC, Chizen DR, Adams GP, Pierson RA. Effects of a single 20 mg dose of letrozole on ovarian function post dominant follicle selection: an exploratory randomized controlled trial. J Ovarian Res. 2017 Jan 21;10(1):6. doi: 10.1186/s13048-017-0303-x.
PubMed 28107821
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatase Inhibitor Effects on Ovarian Function During the Follicular and Early Luteal Phase in Women
- ClinicalTrials.gov ID
- NCT01046578
- Acronym / sponsor ID
- WHIRL-08-1200
- Conditions
- Fertility
- Keywords
- Folliculogenesis, Letrozole, Aromatase Inhibitor, Estrogen
- Phase
- Phase 4
- 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
- Jan 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 12 Jan 2010 (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.
A single center, open label randomized clinical trial designed to examine ovarian follicular dynamics following attempted atresia induction during the late follicular and early luteal phase of the menstrual cycle using an aromatase inhibitor.
We hypothesize that administration of an aromatase inhibitor (AI) at biologically important times of the natural menstrual cycle will cause ovulatory failure in women with preovulatory follicles and failure of luteogenesis in women who have recently ovulated. It is proposed that atresia of the dominant follicle and formation of anovulatory structures will be associated with arrested endometrial development and a shortened interval to menstrual bleeding (3 days). We anticipate that this will provide us with information to facilitate the development of a new method for emergency contraception and a greater understanding of human folliculogenesis.
The rationale for the proposed research project is based on the ovarian synchronization concepts developed and documented in the bovine model in the Reproductive Science and Medicine Research group at the University of Saskatchewan combined with novel human ovarian wave concepts of folliculogenesis first elucidated in the Women's Health Imaging Research Laboratory (WHIRL) in the Department of Obstetrics, Gynecology and Reproductive Sciences.
Detailed description
In clinical practice emergency contraception (EC) intends to suppress follicular development, ovulation, or the ability of a conceptus to implant. Exogenous steroids, estrogen and progestin, are used in various formulations to accomplish the suppression. Though EC are now available 'over-the-counter' in Canada and many countries around the world; the ovarian response is unpredictable and EC do not inhibit ovulation at the most critical times of the menstrual cycle. In 2002 approximately 120,000 of 450,000 pregnancies in Canada ended in elective pregnancy termination. In the US 49% of the 3.5 million annual pregnancies were unintended and 54% of the unintended pregnancies resulted in elective termination.
Current hormonal contraceptive regimens, pre and post coital, are based on the traditional theory of follicular development that states that a single group of antral follicles is recruited in the late luteal phase for growth. Recent documentation has show that human ovarian folliculogenesis occurs in a 2-3 wave like pattern during a menstrual cycle. Wave emergence has been documented to occur in the early luteal phase with the final wave being ovulatory. The new model of follicular wave dynamics is well established and supported by experimental evidence in the bovine and equine models.
Traditionally these hormonal medications are taken 72 to 120 hours after known or suspected barrier contraception failure or unprotected intercourse. The two standard steroidal EC methods are Plan BTM, containing of 0.75 mg levonorgestrel (LNG), and the Yuzpe method, containing 0.1 mg ethinyl estradiol (EE) and 0.5 mg LNG. Ovarian follicular development and ovulation in women have been studied after EC use; however, the mechanisms underlying follicular growth, regression, and ovulation during EC use remain poorly elucidated. The mechanism of action differs with each EC regimen as well as being dependent upon the relative timing between dosing, intercourse, and ovulation. Previous studies have shown that EC are most effective if used when the dominant follicle diameter is small (4 to 5 days prior to ovulation), however, during this time interval intercourse is less likely to result in pregnancy whether or not EC were administered.
All current emergency contraception (EC) options are guided by the traditional theory of follicular development. Based on the findings of an unpredictable response of the ovaries to EC treatment, the occurrence of ovulation after treatment with EC, and findings of follicle growth in a 2-3 wave pattern, we need to reconsider the phase of the menstrual cycle and the treatment given for emergency contraception.
Aromatase inhibitors (AI) prevent the enzymatic conversion of androgens to estrogens. This significantly lowers serum estrogen levels. AI have been administered around the time of menses for ovulation induction and ovulation was seen to follow 10 to 12 days later. The rationale for inducing atresia of dominant follicles stems from this observation. Acute estradiol deprivation should theoretically initiate atresia of all viable follicles in the cohort resulting in the emergence of a new follicle wave without an ovulation event occurring.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Single Dose 12mm follicle | Experimental | Drug: LetrozoleSingle dose (20mg) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 12 mm |
| Single Dose 18mm follicle | Experimental | Drug: LetrozoleSingle dose (20mg) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 18 mm |
| Single Dose Post Ovulation | Experimental | Drug: LetrozoleSingle dose (20mg) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated 24-48 post ovulation |
| Multi Dose 12mm follicle | Experimental | Drug: LetrozoleMulti dose (2.5mg/day for 5 days) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 12 mm |
| Multi Dose 18mm follicle | Experimental | Drug: LetrozoleMulti dose (2.5mg/day for 5 days) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 18 mm |
| Multi Dose Post Ovulation | Experimental | Drug: LetrozoleMulti dose (2.5mg/day for 5 days) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated 24-48 hours post ovulation |
| Control | No intervention | –No intervention given, followed for course of study on a natural cycle |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female subjects of childbearing potential with normal reproductive function;
- Women between 18 and 35 years of age;
- Normal Body Mass Index (18-30);
- Are naïve to OC or have discontinued OC at least 2 months prior to study entry;
- Subject has signed the informed consent form;
Key exclusion criteria (24 listed)
- Irregular menstrual cycles;
- Any contraindication for oral contraception use;
- Known hypersensitivity to Letrozole and co-administered medications;
- Evidence of Polycystic Ovary Syndrome (PCOS) or Endometriosis;
- History of pituitary tumor;
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 |
|---|---|---|
| LetrozoleAlso: Femara (TM)20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 12 mm in diameter | Drug | Single Dose 12mm follicle |
| LetrozoleAlso: Femara (TM)20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 18 mm in diameter | Drug | Single Dose 18mm follicle |
| LetrozoleAlso: Femara (TM)20 mg, one tablet a day for one day, starting 24-48 hours after ovulation of the dominant follicle is observed | Drug | Single Dose Post Ovulation |
| LetrozoleAlso: Femara (TM)2.5 mg, one tablet a day for five days, starting 24-48 hours after ovulation of the dominant follicle is observed | Drug | Multi Dose Post Ovulation |
| LetrozoleAlso: Femara (TM)2.5 mg, one tablet a day for five days, starting on the day the dominant follicle reaches 18 mm in diameter | Drug | Multi Dose 18mm follicle |
| LetrozoleAlso: Femara (TM)2.5 mg, one tablet a day for five days, starting on the day the dominant follicle reaches 18 mm in diameter | Drug | Multi Dose 12mm follicle |
Primary outcome
fate of the dominant follicle or luteal structure
Time frame: 40-45 days
3 secondary outcomes
interval to follicle wave emergence, and interval to selection of a dominant follicle
Time frame: 40-45 days
endometrial thickness/pattern
Time frame: 40-45 days
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 28 Nov 2016.
- Derived from this study: PubMed 28107821Allaway HC, Chizen DR, Adams GP, Pierson RA. Effects of a single 20 mg dose of letrozole on ovarian function post dominant follicle selection: an exploratory randomized controlled trial. J Ovarian Res. 2017 Jan 21;10(1):6. doi: 10.1186/s13048-017-0303-x.
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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, PhD principal investigator
University of Saskatchewan
Donna R Chizen, MD 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 Phase 4 study testing Letrozole in people with Fertility, 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 24 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 28 Nov 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
fate of the dominant follicle or luteal structure (time frame: 40-45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01046578, which also lists 1 linked publication.
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 28 Nov 2016.