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Mid-Luteal Phase Synchronization of Ovarian Folliculogenesis in Women
This study is currently recruiting participants.
Verified by University of Saskatchewan, November 2007
Sponsors and Collaborators: University of Saskatchewan
Canadian Institutes of Health Research (CIHR)
Information provided by: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00565240
  Purpose

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.


Condition Intervention
Ovarian Follicle
Drug: Marvelon
Drug: Evra Patch
Drug: Nuvaring
Drug: Letrozole

Drug Information available for: Letrozole Ortho Evra
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Single Group Assignment
Official Title: Mid-Luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment. [ Time Frame: ongoing ]

Estimated Enrollment: 53
Study Start Date: November 2007
Estimated Study Completion Date: September 2008
Arms Assigned Interventions
Oral Contraceptive: Experimental Drug: Marvelon
oral contraceptive
Contraceptive Patch: Experimental Drug: Evra Patch
contraceptive patch
Contraceptive Ring: Experimental Drug: Nuvaring
contraceptive vaginal ring
Aromatase Inhibitors: Experimental Drug: Letrozole
Aromatase Inhibitors
Control: No Intervention

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. female volunteers of childbearing potential;
  2. are first time users of OC or have discontinued OC at least 2 months prior to study entry;
  3. age between 18 and 35 years old;
  4. normal body mass index (18-30);
  5. has signed consent form; and
  6. is in good health as confirmed by medical history, physical examination

Exclusion Criteria:

  1. a positive pregnancy test will automatically exclude the volunteer from participation in this study.
  2. any contraindication for oral contraception use;
  3. known hypersensitivity to Letrozole and co-administered medications;
  4. irregular menstrual cycles;
  5. ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);
  6. history of pituitary tumor;
  7. HIV, HBV, HCV infection;
  8. vaginal infection;
  9. abnormal ECG;
  10. abnormal lab tests for blood profile, liver function and renal function;
  11. uncontrolled diabetes and blood pressure;
  12. pregnancy (suspected or diagnosed) or lactation;
  13. history or suspicion of drug or alcohol abuse;
  14. history of severe mental disorders;
  15. participation in an investigational drug trial within the 30 days prior to selection;
  16. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565240

Contacts
Contact: Terri Bloski 306-966-7873 bloski@erato.usask.ca
Contact: Roger Pierson 306-655-1000 pierson@erato.usask.ca

Locations
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Principal Investigator: Roger A Pierson            
Sub-Investigator: Femi Olatunbosun            
Sponsors and Collaborators
University of Saskatchewan
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Roger A Pierson University of Saskatchewan
  More Information

Study ID Numbers: WHIRL-07-2971
Study First Received: November 27, 2007
Last Updated: November 28, 2007
ClinicalTrials.gov Identifier: NCT00565240  
Health Authority: United States: Institutional Review Board;   Canada: Health Canada

Keywords provided by University of Saskatchewan:
ovarian synchronization
folliculogenesis

Study placed in the following topic categories:
Ortho Evra
Letrozole

ClinicalTrials.gov processed this record on January 15, 2009