Study Completed

Therapeutic Equivalency, Biological Availability, Postmenopause

Bayer Identifier:

91340

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study to investigate the bioequivalence and bioavailability of different formulations containing 0.030 mg Ethinylestradiol and 0.125 mg Levonorgestrel in postmenopausal women

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A

Trial summary

Enrollment Goal

Trial Dates

May 2004 - September 2004

Phase

Phase 1

Could I Receive a placebo

N/A

Products

Minisiston/Monostep (EE30/LNG, BAY86-4977)

Accepts Healthy Volunteer

N/A

Primary Outcome

Secondary Outcome

Trial design

Open-label, randomized, crossover study to investigate the bioequivalence of two different tablet formulations containing 0.030 mg ethinylestradiol and 0.125 mg levonorgestrel (with gelatin [SH D00133A] versus gelatinfree [SH D00342A]) and to compare the bioavailability of the gelatincontaining formulation to that of a microcrystalline suspension [SH M00133A] in healthy postmenopausal women

Trial Type

Interventional

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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