HemostasisPhase 2NCT01388491
A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
A Phase 2 study testing desogestrel/ethinyl estradiol and ethinyl estradiol and desogestrel/ethinyl estradiol in people with Hemostasis and Oral Contraceptive, run by Teva Branded Pharmaceutical Products R&D, Inc. at 27 sites in 4 countries.
Trial summary
This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemostasis, Oral Contraceptive
- What is being tested?
- desogestrel/ethinyl estradiol and ethinyl estradiol and desogestrel/ethinyl estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 27 sitesin 4 countries
- Study dates
- 31 Oct 2011to 30 Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal, non-pregnant, non-lactating women age 18-40 years old
- Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
- Regular spontaneous menstrual cycle
- Others as dictated by FDA-approved protocol
Who cannot join
- Any condition which contraindicates the use of combination oral contraceptives
- Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
- Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders
- Others as dictated by FDA-approved protocol
Trial locations and contacts
27 sites in 4 countries.
27 sites in 4 countries
Spain8 sites
Teva Investigational Site 31017
Barcelona, 08025
Teva Investigational Site 31015
Barcelona, 08028
Teva Investigational Site 31014
Barcelona, 08035
Teva Investigational Site 31016
Gava, Barcelona, 08850
Teva Investigational Site 31012
Lugo, 27002
Teva Investigational Site 31010
Madrid, 28001
Teva Investigational Site 31011
Madrid, 28009
Teva Investigational Site 31009
Vitoria-Gasteiz, 01004
Italy7 sites
Teva Investigational Site 30014
Brescia, 25123
Teva Investigational Site 30009
Cagliari, 09124
Teva Investigational Site 30012
Catania, 95123
Teva Investigational Site 30013
Naples, 80131
Teva Investigational Site 30010
Pavia, 27100
Teva Investigational Site 30007
Pisa, 56126
Teva Investigational Site 30016
Siena, 53100
Germany6 sites
Teva Investigational Site 32064
Essen, 45127
Teva Investigational Site 32065
Frankfurt, 60311
Teva Investigational Site 32066
Frankfurt am Main, 60439
Teva Investigational Site 32062
Hamburg, 22159
Teva Investigational Site 32063
Hamburg, 22359
Teva Investigational Site 32061
Magdeburg, 39112
Israel6 sites
Teva Investigational Site 80013
Giv‘atayim, 53425
Teva Investigational Site 80015
Haifa, 34466
Teva Investigational Site 80017
Modiin, 71705
Teva Investigational Site 80014
RishonLe'zio
Teva Investigational Site 80018
Tel Aviv, 62304
Teva Investigational Site 80016
Tel Aviv, 69379
About this study
Official title: A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of DR-102 Compared to a 28-day Standard Oral Contraceptive Regimen, on Hemosatic Parameters in Healthy Women
This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.
- Conditions
- Hemostasis, Oral Contraceptive
- Being tested
- desogestrel/ethinyl estradiol and ethinyl estradiol, desogestrel/ethinyl estradiol
- 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.
desogestrel/ethinyl estradiol and ethinyl estradiolDrug
desogestrel/ethinyl estradiolDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment I: (DR-102) | Experimental | 21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles Receives: Drug: desogestrel/ethinyl estradiol and ethinyl estradiol |
| Treatment II | Active comparator | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles Receives: Drug: desogestrel/ethinyl estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels
Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Secondary outcomes (13)
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer
Normal range for this hemostatic parameter was 0 to 729 mcg/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen
The normal range for this hemostatic parameter was 50% to 147%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity
The normal range for this hemostatic parameter was 70% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin
Normal range for this hemostatic parameter was 75% to 130%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity
Normal range for this hemostatic parameter was 70% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII
Normal range for this hemostatic parameter was 60% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII
Normal range for this hemostatic parameter was 50% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance
This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 2.00 to 3.36. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance
This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 0.32 to 1.79. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin
Normal range for this adrenal parameter was 1906.448 to 4520.504 mg/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol
Normal range for this adrenal parameter was 85.6 to 618.2 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)
Normal range for this parameter was 0.35 to 5.5 mIU/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin
Normal range for this parameter was 28 to 146 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Measured: Baseline through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study start31 Oct 2011
- Primary completion30 Sep 2012
- Study completion30 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemostasisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Women's Health Research Protocol Chair, Study chair, Teva Women's Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388491
- Sponsor's protocol ID
- DSG-HSP-201
- Status last verified
- Dec 2021
- First submitted
- 1 Jul 2011
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Peters K, Gordon N, Ricciotti N, Hsieh J, Howard B, Weiss H. Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study. Clin Exp Obstet Gynecol. 2016;43(3):334-40.
PubMed 27328486
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of DR-102 Compared to a 28-day Standard Oral Contraceptive Regimen, on Hemosatic Parameters in Healthy Women
- ClinicalTrials.gov ID
- NCT01388491
- Acronym / sponsor ID
- DSG-HSP-201
- Conditions
- Hemostasis, Oral Contraceptive
- Keywords
- Contraception, Hemostasis, Blood Coagulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2011 (actual)
- Primary completion
- 30 Sep 2012 (actual)
- Study completion
- 30 Sep 2012 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Posted 27 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment I: (DR-102) | Experimental | Drug: desogestrel/ethinyl estradiol and ethinyl estradiol21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles |
| Treatment II | Active comparator | Drug: desogestrel/ethinyl estradiol21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Premenopausal, non-pregnant, non-lactating women age 18-40 years old
- Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
- Regular spontaneous menstrual cycle
- Others as dictated by FDA-approved protocol
Key exclusion criteria (4 listed)
- Any condition which contraindicates the use of combination oral contraceptives
- Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
- Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders
- Others as dictated by FDA-approved protocol
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 |
|---|---|---|
| desogestrel/ethinyl estradiol and ethinyl estradiol | Drug | Treatment I: (DR-102) |
| desogestrel/ethinyl estradiol | Drug | Treatment II |
Primary outcome
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels
Time frame: Baseline through Month 6
Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
13 secondary outcomes
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)
Time frame: Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin
Time frame: Baseline through Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27328486Peters K, Gordon N, Ricciotti N, Hsieh J, Howard B, Weiss H. Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study. Clin Exp Obstet Gynecol. 2016;43(3):334-40.
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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.
Teva Women's Health Research Protocol Chair study chair
Teva Women's Health Research
27 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing desogestrel/ethinyl estradiol and ethinyl estradiol and desogestrel/ethinyl estradiol in people with Hemostasis and Oral Contraceptive, run by Teva Branded Pharmaceutical Products R&D, Inc. at 27 sites in 4 countries.
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 4 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 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Spain, Italy, Germany, Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels (time frame: Baseline through Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01388491, which also lists 1 linked publication.
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 6 Dec 2021.