Trial Outcomes & Findings for Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive (NCT NCT00196326)
NCT ID: NCT00196326
Last Updated: 2016-11-16
Results Overview
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
COMPLETED
PHASE3
2235 participants
up to one year
2016-11-16
Participant Flow
A total of 2968 subjects were screened and 2235 subjects were enrolled in the study. Of those enrolled, 2185 took at least one dose of study medication.
Participant milestones
| Measure |
DR-1011
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
|
|---|---|
|
Overall Study
STARTED
|
2235
|
|
Overall Study
Safety Population
|
2185
|
|
Overall Study
Pregnancy Intent-to-treat Cohort (PITT)
|
1735
|
|
Overall Study
COMPLETED
|
1249
|
|
Overall Study
NOT COMPLETED
|
986
|
Reasons for withdrawal
| Measure |
DR-1011
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
|
|---|---|
|
Overall Study
Did not meet protocol requirements
|
64
|
|
Overall Study
Non-compliance with the protocol
|
81
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
225
|
|
Overall Study
Adverse Event
|
253
|
|
Overall Study
Pregnancy
|
34
|
|
Overall Study
Lost to Follow-up
|
304
|
|
Overall Study
Other
|
22
|
Baseline Characteristics
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
Baseline characteristics by cohort
| Measure |
DR-1011
n=2185 Participants
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
|
|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 5.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2185 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
256 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
36 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1627 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
218 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
48 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2185 participants
n=5 Participants
|
|
Weight
|
158.7 pounds
STANDARD_DEVIATION 41.26 • n=5 Participants
|
|
Body Mass Index
|
26.7 kg/m^2
STANDARD_DEVIATION 6.65 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to one yearPopulation: The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
Outcome measures
| Measure |
DR-1011
n=1735 Participants
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
|
|---|---|
|
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Excluding other BCMs (n=1732)
|
2.44 pregnancies per 100 woman years exposure
|
|
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
All complete cycles (n=1735)
|
2.42 pregnancies per 100 woman years exposure
|
|
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Compliant-Use (n=1685)
|
1.77 pregnancies per 100 woman years exposure
|
PRIMARY outcome
Timeframe: up to one yearPopulation: The pregnancy intent-to-treat cohort (PITT) consisted of subjects between the ages of 18 and 35 who were randomized to treatment and completed at least one cycle of study medication.
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
Outcome measures
| Measure |
DR-1011
n=1735 Participants
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
|
|---|---|
|
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Excluding other BCMs (n=1732)
|
2.15 pregnancies per 100 woman years exposure
|
|
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
All complete cycles (n=1735)
|
2.12 pregnancies per 100 woman years exposure
|
|
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Compliant-Use (n=1685)
|
1.77 pregnancies per 100 woman years exposure
|
SECONDARY outcome
Timeframe: Day 1 up to one yearPopulation: The safety cohort consisted of all patient who took at least one dose of study medication
Safety was assessed by summarizing adverse events recorded in the patient's daily diary and reported by subjects at each study visit, and by summarizing results of examination, vital signs and clinical laboratory values.
Outcome measures
| Measure |
DR-1011
n=2185 Participants
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
|
|---|---|
|
Participants With Treatment-Emergent Adverse Events
|
1742 participants
|
Adverse Events
DR-1011
Serious adverse events
| Measure |
DR-1011
n=2185 participants at risk
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
|
|---|---|
|
General disorders
ABDOMINAL PAIN UPPER
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION MISSED
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.18%
4/2185 • Number of events 4 • Day 1 up to one year
|
|
Infections and infestations
APPENDICITIS
|
0.09%
2/2185 • Number of events 2 • Day 1 up to one year
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.09%
2/2185 • Number of events 2 • Day 1 up to one year
|
|
Hepatobiliary disorders
BILIARY DILATATION
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Hepatobiliary disorders
BILIARY DYSKINESIA
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Nervous system disorders
CERVICOBRACHIAL SYNDROME
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.09%
2/2185 • Number of events 2 • Day 1 up to one year
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Surgical and medical procedures
CLEFT PALATE REPAIR
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Pregnancy, puerperium and perinatal conditions
CONGENITAL GENITAL MALFORMATION MALE
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Psychiatric disorders
DEPRESSION
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Psychiatric disorders
DEPRESSION SUICIDAL
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Social circumstances
DRUG ABUSER
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Infections and infestations
GASTROENTERITIS
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Nervous system disorders
HEADACHE
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Infections and infestations
MENINGITIS VIRAL
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE LABOUR
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Infections and infestations
PYELONEPHRITIS
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Nervous system disorders
SYNCOPE
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
|
Injury, poisoning and procedural complications
WOUND DECOMPOSITION
|
0.05%
1/2185 • Number of events 1 • Day 1 up to one year
|
Other adverse events
| Measure |
DR-1011
n=2185 participants at risk
Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.0%
175/2185 • Number of events 268 • Day 1 up to one year
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
11.4%
250/2185 • Number of events 460 • Day 1 up to one year
|
|
Nervous system disorders
HEADACHE
|
33.5%
732/2185 • Number of events 2495 • Day 1 up to one year
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
8.4%
183/2185 • Number of events 291 • Day 1 up to one year
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.6%
362/2185 • Number of events 528 • Day 1 up to one year
|
|
Gastrointestinal disorders
NAUSEA
|
8.7%
190/2185 • Number of events 272 • Day 1 up to one year
|
|
Infections and infestations
SINUSITIS
|
7.2%
157/2185 • Number of events 198 • Day 1 up to one year
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
8.0%
174/2185 • Number of events 223 • Day 1 up to one year
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.4%
118/2185 • Number of events 147 • Day 1 up to one year
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can (i) review results communications prior to public release and can embargo communications regarding trial results for a period of at least 60 days but no more than 180 days from the time submitted to the sponsor for review; and (ii) require in instances of a multi-center study, that a single PI not disclose study data until after the multi-center results are published, provided such results are published within eighteen (18) months of the conclusion of the study.
- Publication restrictions are in place
Restriction type: OTHER