AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Canada1 site
  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

Other trials in Canada

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.

Conditions
Fertility
Being tested
Letrozole
Keywords
Folliculogenesis, Letrozole, Aromatase Inhibitor, Estrogen

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 groups in NCT01046578
Study groupRoleWhat they receive
Single Dose 12mm follicleExperimentalSingle dose (20mg) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 12 mm
Receives: Drug: Letrozole
Single Dose 18mm follicleExperimentalSingle dose (20mg) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated at follicle diameter of 18 mm
Receives: Drug: Letrozole
Single Dose Post OvulationExperimentalSingle dose (20mg) of an aromatase inhibitor (Letrozole/Femara(TM); n = 10) initiated 24-48 post ovulation
Receives: Drug: Letrozole
Multi Dose 12mm follicleExperimentalMulti 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 follicleExperimentalMulti 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 OvulationExperimentalMulti 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
ControlNo interventionNo 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.

  1. fate of the dominant follicle or luteal structure

    Measured: 40-45 days

Secondary outcomes (3)
  1. interval to follicle wave emergence, and interval to selection of a dominant follicle

    Measured: 40-45 days

  2. endometrial thickness/pattern

    Measured: 40-45 days

  3. 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.

  1. First posted12 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in