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Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
This study has been completed.
Study NCT00196326   Information provided by Duramed Research
First Received: September 12, 2005   Last Updated: July 23, 2009   History of Changes
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition: Contraception
Intervention: Drug: DR-1011

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
DR-1011 Investigational Drug: Take 1 tablet daily

Participant Flow:   Overall Study
  DR-1011
STARTED   2185[1]
COMPLETED   1249  
NOT COMPLETED   936  
[1] Took at least one dose of study medication



  Baseline Characteristics
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Reporting Groups
  Description
DR-1011 Investigational Drug: Take 1 tablet daily

Baseline Measures
  DR-1011
Number of Participants  
[units: participants]
 		2185
Age  
[units: years]
Mean ± Standard Deviation 		27.7 ± 5.80
Gender  
[units: participants]
 		 
Female 2185
Male 0
Region of Enrollment  
[units: participants]
 		 
United States 2185



  Outcome Measures
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1.  Primary:   Pregnancy Rate (Pearl Index)   [ After the onset of treatment and within 14 days after the last combination pill (approx. 1 year of treatment) ]
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2.  Secondary:   Adverse Events Reported by Patients and Investigators   [ Up to one year ]
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  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
DR-1011 Investigational Drug: Take 1 tablet daily

Serious Adverse Events
  DR-1011
Total, serious adverse events  
# participants affected 34  
Blood and lymphatic system disorders  
Leukocytosis   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Cardiac disorders  
Worsening Paroxysymal Supraventricular Tachycardia   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Gastrointestinal disorders  
Right Upper Quadrant Pain   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Hepatobiliary disorders  
Cholelithiasis with Biliary Colic   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Symptomatic Cholelithiasis   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Biliary Dyskinesia   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Dilated Biliary Common Duct   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Cholecystitis   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Infections and infestations  
Gastroenteritis   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Viral Meningitis   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Appendicitis   *
      # participants affected / at risk
      # events
2/2185 (0.09%)
2  
Strep Throat   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Pyelonephritis   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Injury, poisoning and procedural complications  
Tylenol Overdose   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Right Tibial Fracture   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Surgical Wound Breakdown   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Right Orbital Floor Facial Fracture   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Broken Collarbone   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Musculoskeletal and connective tissue disorders  
Back Pain Related to Spinal Stenosis   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Nervous system disorders  
Cervical Radiculopathy   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Intermittent Headache   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Syncope   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Back Pain Related to Herniated Disc   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Pregnancy, puerperium and perinatal conditions  
Premature Labor   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Ectopic Pregnancy   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Miscarriage   *
      # participants affected / at risk
      # events
3/2185 (0.14%)
3  
Missed Abortion   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Hypospadias of Infant   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Spontaneous Abortion   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Psychiatric disorders  
Severe Depression with Suicidal Ideation   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Depression   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Respiratory, thoracic and mediastinal disorders  
Exacerbated Asthma   *
      # participants affected / at risk
      # events
2/2185 (0.09%)
2  
Skin and subcutaneous tissue disorders  
Urticaria   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Social circumstances  
Illicit Drug Use   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
Surgical and medical procedures  
Cleft Palate Repair   *
      # participants affected / at risk
      # events
1/2185 (0.05%)
1  
* Indicates events were collected by non-systematic assessment.


  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Duramed Research Protocol Chair
Organization: Duramed Research
phone: 215-293-7279
e-mail: medicalaffairs@barrlabs.com


No publications provided


Responsible Party: Duramed Research, Inc. ( Druamed Protocol Chair )
Study ID Numbers: DR-PSE-309
Study First Received: September 12, 2005
Results First Received: November 21, 2008
Last Updated: July 23, 2009
ClinicalTrials.gov Identifier: NCT00196326     History of Changes
Health Authority: United States: Food and Drug Administration





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