HealthyPhase 4NCT00651846
Investigate Impact of Yasmin vs Microgynon on Hemostasis Parameters in Healthy Women
A Phase 4 study testing Yasmin (DRSP 3mg/EE 0.03 mg) and Microgynon (LNG 0.15 mg/EE 0.03 mg) in people with Healthy, run by Bayer at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Yasmin (DRSP 3mg/EE 0.03 mg) and Microgynon (LNG 0.15 mg/EE 0.03 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2003to Feb 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically normal safety laboratory results
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Healthy
- Being tested
- Yasmin (DRSP 3mg/EE 0.03 mg), Microgynon (LNG 0.15 mg/EE 0.03 mg)
- Keywords
- Contraception, Hemostasis, Blood Coagulation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yasmin (DRSP 3mg/EE 0.03 mg)Drug
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).
Microgynon (LNG 0.15 mg/EE 0.03 mg)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Yasmin (DRSP 3mg/EE 0.03 mg) |
| Arm 2 | Active comparator | Not described Receives: Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pro-coagulatory parameters: Factor VIII (activity), Fibrinogen
Measured: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Anti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation)
Measured: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Secondary outcomes (2)
Rosing test: APC sensitivity ratio
Measured: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Pro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2
Measured: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startJun 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651846
- Sponsor's protocol ID
- 91270
- Other IDs
- 307286
- Status last verified
- Dec 2014
- First submitted
- 1 Apr 2008
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00651846
- Acronym / sponsor ID
- 91270
- Conditions
- Healthy
- Keywords
- Contraception, Hemostasis, Blood Coagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Feb 2005 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Yasmin (DRSP 3mg/EE 0.03 mg) |
| Arm 2 | Active comparator | Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinically normal safety laboratory results
Key exclusion criteria (4 listed)
- Standard contraindications for use of combined oral contraceptives (class label). Including:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Arm 1 |
| 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). | Drug | Arm 2 |
Primary outcome
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yasmin (DRSP 3mg/EE 0.03 mg) and Microgynon (LNG 0.15 mg/EE 0.03 mg) in people with Healthy, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.