Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Information source: EMD Serono
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anovulation
Intervention: Anastrozole 1mg (Drug); Anastrozole 5mg dose (Drug); Anastrozole 10mg dose (Drug); Clomiphene Citrate 50mg (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: EMD Serono Official(s) and/or principal investigator(s): Donald R Tredway, M.D., PhD, Study Director, Affiliation: EMD Serono
Summary
The purpose of this study is to investigate and compare the safety and efficacy of various
doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating
follicular growth and ovulation in infertile women with ovulatory dysfunction.
Clinical Details
Official title: A Phase II, Prospective, Randomized, Double-Blind, Multicenter, Dose Finding, Comparative Study for the Evaluation of the Aromatase Inhibitor Anastrozole (Multiple-Dose) Versus Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Ovulation
Secondary outcome: Pregnancy
Detailed description:
This is a multicenter, randomized, double-blind study. Upon the provision of Informed
Consent, subjects will be screened for entry during the menstrual cycle prior to the
anticipated start of treatment. All screening assessments should be completed within 6
weeks of treatment, unless otherwise noted.
Subjects who meet screening requirements will be equally randomized to one of the three
following treatment arms:
- Anastrozole 1 mg/day for 5 days
- Anastrozole 5 mg/day for 5 days
- Clomiphene citrate 50 mg/day for 5 days Treatment will begin at cycle day 2 or 3 of
their subsequent menses (cycle day 1 = first day of full bleed).
Subjects will return to the clinic on Stimulation Days 3 or 4 and 6 or 7 (note: Stimulation
Day 1 equals the first day of study drug) for blood sampling and ultrasounds. Ultrasound
and serum monitoring will be repeated every 2 days thereafter until a lead follicle reaches
a mean diameter of ³ 14 mm, and then daily until an LH surge occurs. Monitoring will be
discontinued if a lead follicle ³ 14 mm has not developed by Stim Day 18 of the cycle
(inadequate treatment cycle) with a serum progesterone being obtained one week after
discontinuing monitoring.
A subgroup of subjects will be selected for additional pharmacokinetic and pharmacodynamic
analysis during Cycle 1 only. Blood samples will be collected at selected timepoints for
analysis of anastrozole/clomiphene citrate, estradiol, FSH, LH, androstendione, and
testosterone. This subgroup will consist of approximately 40-50 subjects and will be carried
out at predetermined investigative centers.
Insemination will occur via intercourse or IUI within 24 hours following the LH surge.
Subjects will return to the center during the mid-luteal phase for a pelvic ultrasound and
blood sample for local and central progesterone on day 6 or 7 after the LH surge, and will
also return for a repeat blood sample for progesterone on day 8 or 9 after the LH surge.
Ovulation will be confirmed by a progesterone level ³ 10 ng/mL. If the results of the
progesterone test indicate that the patient has not ovulated, the subject will be brought
back one to two days later for a repeat progesterone test.
In ovulatory cycles, a pregnancy test will be performed between days 15 and 20 post-LH
surge. Subjects with a positive pregnancy test will have the test repeated within 2 to 4
days and will return to the clinic between days 35-42 post-LH surge for a confirmatory
ultrasound.
Subjects may be allowed to continue for up to two additional treatment cycles if they failed
to achieve clinical pregnancy in their first treatment cycle, and did not experience an SAE
or other mandatory withdrawal condition. Subsequent treatments will be assigned at the same
dose as the randomized dose for each subject.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Aged 18-40
- Ovulatory dysfunction characterized by irregular and/or extended cycles
- Non-smoker
Exclusion Criteria:
- No previous gonadotropin treatment
- No more than 6 previous clomiphene treatment cycles
Locations and Contacts
Local US Medical Information, Rockland, Massachusetts 02370, United States
Additional Information
Starting date: March 2005
Last updated: August 5, 2014
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