Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

NCT00565240 | Completed

• 1 other identifier: WHIRL-07-59
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

ovarian synchronization; folliculogenesis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  ongoing

Study Arms (4)

Oral Contraceptive

EXPERIMENTAL

Drug: Marvelon

Contraceptive Ring

EXPERIMENTAL

Drug: Nuvaring

Aromatase Inhibitors

EXPERIMENTAL

Drug: Letrozole

Control

NO INTERVENTION

Interventions

Marvelon DRUG

oral contraceptive

Oral Contraceptive

Nuvaring DRUG

contraceptive vaginal ring

Contraceptive Ring

Letrozole DRUG

Aromatase Inhibitors

Aromatase Inhibitors

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• University of Saskatchewan: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Interventions

Desogestrel; NuvaRing; Letrozole

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Roger A Pierson

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 29, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 22, 2010

Record last verified: 2010-04

Locations

CA (1)