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A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction

NCT00230815 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2013-11-28

No results posted yet for this study

Summary

This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and efficacy with follitropin alfa injection applied by Pen device compared with the subject's previous experience with injectable gonadotropins in oligoanovulatory infertile women undergoing ovulation induction

Conditions

Interventions

DEVICE

Follitropin alfa injected by Pen device

Follitropin alfa will be injected subcutaneously by Pen device at a dose of 75 International Unit (IU) and 150 IU in subjects aged 18-34 and 35-40 years, respectively, for 5 days. Dose will be adjusted on stimulation Day 6 until ovulation triggering criteria will met.

DEVICE

Recombinant Human Choriogonadotropin (r-hCG)

Recombinant Human Choriogonadotropin (r-hCG) injection will be administered as a single dose of 250 microgram subcutaneously when at least 1 follicle, but not more than 3 follicles, reached a mean diameter greater than or equal to (\>=)17 mm and estradiol levels are approximately 150 picogram per milliliter (pg/mL) per mature follicle.

Sponsors & Collaborators

Principal Investigators

  • Eduardo Kelly, MD, MBA · Sponsor GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2005-11-30
Completion
2005-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00230815 on ClinicalTrials.gov