A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale - Full Text View

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-1031 Drug: Seasonale® Drug: Portia®	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

Resource links provided by NLM:

Drug Information available for: Estradiol Ethinyl Estradiol Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate Estradiol hemihydrate

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Bleeding is defined as a flow heavy enough to require sanitary protection.
Time to First Bleeding Day [ Time Frame: Day 1-84 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Enrollment:	567
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: 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: levonorgestrel/ethinyl estradiol Quartette® 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: levonorgestrel/ethinyl estradiol Quartette® 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: levonorgestrel/ethinyl estradiol Quartette® 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

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394771

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Sponsors and Collaborators

Duramed Research

Investigators

Principal Investigator:

Duramed Medical Monitor

Duramed Research

More Information

No publications provided

Responsible Party:	Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:	NCT00394771 History of Changes
Other Study ID Numbers:	DR-ASC-201
Study First Received:	October 30, 2006
Results First Received:	April 25, 2013
Last Updated:	April 25, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:

oral contraceptives
breakthrough bleeding
spotting

Additional relevant MeSH terms:

Hemorrhage
Metrorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral

Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on June 18, 2013