Investigate Impact of Yasmin vs Microgynon on Hemostasis Parameters in Healthy Women - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00651846

Purpose

The objective of this study was to investigate the impact of the oral contraceptive YASMIN (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on factors of blood coagulation and fibrinolysis in female subjects

Condition	Intervention	Phase
Healthy	Drug: Yasmin (DRSP 3mg/EE 0.03 mg) Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Single Center, Double Blind, Randomized, Crossover Study to Investigate the Impact of the Oral Contraceptive Yasmin (30 µg EE / 3 mg DRSP) Compared to Microgynon (30 µg / 150 LNG) on Hemostasis Parameters in 40 Female Volunteers

Resource links provided by NLM:

Drug Information available for: Ethinyl estradiol-norgestrel combination

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Pro-coagulatory parameters: Factor VIII (activity), Fibrinogen [ Time Frame: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods ] [ Designated as safety issue: No ]
Anti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation) [ Time Frame: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rosing test: APC sensitivity ratio [ Time Frame: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods ] [ Designated as safety issue: No ]
Pro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2 [ Time Frame: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	June 2003
Study Completion Date:	February 2005

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Yasmin (DRSP 3mg/EE 0.03 mg) The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack. Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (3mg DRSP/0.03 mgEE). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).
Active Comparator: Arm 2	Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg) The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack. Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (LNG 0.15 mg/EE 0.03 mg). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).

Arms

Assigned Interventions

Experimental: Arm 1

Drug: Yasmin (DRSP 3mg/EE 0.03 mg)

The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.

Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (3mg DRSP/0.03 mgEE). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).

Active Comparator: Arm 2

Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg)

The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.

Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (LNG 0.15 mg/EE 0.03 mg). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Clinically normal safety laboratory results

Exclusion Criteria:

Standard contraindications for use of combined oral contraceptives (class label).
Including:
Presence or history of thromboembolic process in veins (such as deep venous thrombosis, pulmonary embolism) or arteries (e.g., stroke, myocardial infarction) or a known genetic component (homozygous), venous thromboembolic event in a close relative (parents or siblings) at younger age (</= 40 years).
Acute and chronic severe liver dysfunction or disease. There should be an interval of at least 6 months between the subsidence of a viral hepatitis (normalization of the liver parameters) and the start of the study medication.
Use of preparations where experience shows affect on the activity of hepatic enzymes.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651846

Locations

Germany

Berlin, Germany, 10115

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG, Medical Affairs Therapeutic Area Head
ClinicalTrials.gov Identifier:	NCT00651846 History of Changes
Other Study ID Numbers:	91270, 307286
Study First Received:	April 1, 2008
Last Updated:	April 7, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Contraception
Hemostasis
Blood Coagulation

Additional relevant MeSH terms:

Contraceptives, Oral
Ethinyl Estradiol-Norgestrel Combination
Ethinyl estradiol, levonorgestrel drug combination
Hemostatics
Drospirenone and ethinyl estradiol combination
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Coagulants
Hematologic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital

ClinicalTrials.gov processed this record on February 09, 2012