A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00394771 |
|
Recruitment Status :
Completed
First Posted : November 1, 2006
Results First Posted : June 19, 2013
Last Update Posted : July 26, 2013
|
Sponsor:
Duramed Research
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc. ( Duramed Research )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breakthrough Bleeding | Drug: DR-1031 Drug: Seasonale® Drug: Portia® | Phase 2 |
This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.
Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,
The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 567 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen |
| Study Start Date : | October 2006 |
| Actual Primary Completion Date : | March 2008 |
| Actual Study Completion Date : | March 2008 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Low Dose DR-1031
42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Drug: DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Other Names:
Drug: Portia® Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other Name: levonorgestrel/ethinyl estradiol |
|
Experimental: Midrange Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Drug: DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Other Names:
Drug: Portia® Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other Name: levonorgestrel/ethinyl estradiol |
|
Experimental: High Dose DR-1031
21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
|
Drug: DR-1031
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Other Names:
Drug: Portia® Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other Name: levonorgestrel/ethinyl estradiol |
|
Active Comparator: Seasonale
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
|
Drug: Seasonale®
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
Other Name: levonorgestrel/ethinyl estradiol Drug: Portia® Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other Name: levonorgestrel/ethinyl estradiol |
Primary Outcome Measures :
- Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ]Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
- Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ]Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Secondary Outcome Measures :
- Days With Bleeding During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ]Bleeding is defined as a flow heavy enough to require sanitary protection.
- Days With Bleeding During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ]Bleeding is defined as a flow heavy enough to require sanitary protection.
- Time to First Bleeding Day [ Time Frame: Day 1-84 ]
Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection.
Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding.
- Maximum Bleeding Severity During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ]
Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.
Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity.
See pre-specified analyses for Number of Moderate to Heavy Bleeding Days.
- Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91) [ Time Frame: Day 85-91 ]Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.
- Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183) [ Time Frame: Day 177-183 ]Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.
- Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ]Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
- Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ]Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
- Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91) [ Time Frame: Day 85-91 ]Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
- Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183) [ Time Frame: Day 177-183 ]Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Other Outcome Measures:
- Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ]Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.
- Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ]Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Premenopausal
- Not pregnant or breastfeeding
- Agree to use back-up non-hormonal contraception for study period
Exclusion Criteria:
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking >10 cigarettes per day
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394771
Locations
Show 50 study locations
Sponsors and Collaborators
Duramed Research
Investigators
| Principal Investigator: | Duramed Medical Monitor | Duramed Research |
| Responsible Party: | Duramed Research |
| ClinicalTrials.gov Identifier: | NCT00394771 |
| Other Study ID Numbers: |
DR-ASC-201 |
| First Posted: | November 1, 2006 Key Record Dates |
| Results First Posted: | June 19, 2013 |
| Last Update Posted: | July 26, 2013 |
| Last Verified: | July 2013 |
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc. ( Duramed Research ):
|
oral contraceptives breakthrough bleeding spotting |
Additional relevant MeSH terms:
|
Metrorrhagia Hemorrhage Pathologic Processes Uterine Hemorrhage Uterine Diseases Estradiol 17 beta-cypionate Estradiol 3-benzoate Levonorgestrel Ethinyl Estradiol Estradiol Polyestradiol phosphate |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptives, Oral, Hormonal |