A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale.
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breakthrough Bleeding |
Drug: DR-1031a Drug: DR-1031b Drug: DR-1031c Drug: Seasonale |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- Total number of bleeding and/or spotting days during active treatment period. [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
- Total number of bleeding days during active treatment period [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
- Timing and severity of bleeding [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
- Onset,duration,severity of scheduled withdrawal bleeding [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
- Number of subjects reporting hormone-related symptoms [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]
- Adverse events reported by subjects and investigators [ Time Frame: Active treatment period ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2006 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: DR-1031a
1 tablet daily
|
| Experimental: 2 |
Drug: DR-1031b
1 tablet daily
|
| Experimental: 3 |
Drug: DR-1031c
1 tablet daily
|
| Active Comparator: 4 |
Drug: Seasonale
1 tablet daily
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Show 50 Study Locations| Principal Investigator: | Duramed Medical Monitor | Duramed Research |
More Information
No publications provided
| Responsible Party: | Duramed Research, Duramed Research, Inc |
| ClinicalTrials.gov Identifier: | NCT00394771 History of Changes |
| Other Study ID Numbers: | DR-ASC-201 |
| Study First Received: | October 30, 2006 |
| Last Updated: | June 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Duramed Research:
|
oral contraceptives breakthrough bleeding spotting |
Additional relevant MeSH terms:
|
Hemorrhage Metrorrhagia Pathologic Processes Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Contraceptive Agents Ethinyl estradiol, levonorgestrel drug combination |
Contraceptives, Oral Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Contraceptives, Oral, Combined |
ClinicalTrials.gov processed this record on June 17, 2013