Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00213148
First received: September 13, 2005
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Anovulation
Drug: Anastrozole 1mg
Drug: Anastrozole 5mg dose
Drug: Anastrozole 10mg dose
Drug: Clomiphene Citrate 50mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Ovulation [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 307
Study Start Date: March 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Anastrozole 1mg
Anastrozole 1mg, once per day for 5 days.
Experimental: 2 Drug: Anastrozole 5mg dose
Anastrozole 5mg, once per day for 5 days.
Experimental: 3 Drug: Anastrozole 10mg dose
Anastrozole 10mg, once per day for 5 days.
Active Comparator: 4 Drug: Clomiphene Citrate 50mg
Clomiphene Citrate 50mg, once per day for 5 days.

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213148

Locations
United States, Massachusetts
Local US Medical Information
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Donald R Tredway, M.D., PhD EMD Serono, Inc.
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00213148     History of Changes
Other Study ID Numbers: 25550
Study First Received: September 13, 2005
Last Updated: August 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anovulation
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Anastrozole
Aromatase Inhibitors
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014