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Treatment of Menstrually Related Disorders With Continuous v. Interrupted Oral Contraceptives

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ClinicalTrials.gov Identifier: NCT00089414
Recruitment Status : Terminated (Informed by manufacturer that CDB-2914 crosses blood-brain barrier invalidating Arm #3 of protocol.)
First Posted : August 5, 2004
Results First Posted : January 2, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Premenstrual Syndrome
PMS
Premenstrual Dysphoric Disorder
PMDD
Depression
Interventions: Drug: Ethinyl Estradiol/Drospirenone
Drug: Placebo
Drug: CDB 2914

  Participant Flow

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
Continuous Yasmin Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
Interrupted Yasmin Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
Continuous Yasmin Plus Progesterone Antagonist Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.

Participant Flow:   Overall Study
    Continuous Yasmin   Interrupted Yasmin   Continuous Yasmin Plus Progesterone Antagonist
STARTED   2   1   2 
COMPLETED   2   1   2 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Continuous OCP Plus Placebo Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
Interrupted OC Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
Continuous OC Plus PR Antagonist Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
Total Total of all reporting groups

Baseline Measures
   Continuous OCP Plus Placebo   Interrupted OC   Continuous OC Plus PR Antagonist   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   1   2   5 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      2 100.0%      1 100.0%      2 100.0%      5 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.5  (6.364)   41  (0)   34.5  (2.121)   34.6  (3.8794) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      2 100.0%      1 100.0%      2 100.0%      5 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   2   1   2   5 


  Outcome Measures

1.  Primary:   Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms.   [ Time Frame: Every 2 weeks for 3 months ]

2.  Secondary:   Change in Clinical Global Impression Scale (CGI) Factors Associated With Premenstrual Symptoms.   [ Time Frame: Every 2 wks for 3 months ]

3.  Secondary:   Change in Beck Depression Inventory (BDI) Factors Associated With Premenstrual Symptoms   [ Time Frame: Every 2 weeks for 3 months ]


  Serious Adverse Events


  Other Adverse Events


  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
Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential CNS effect of the compound on behavior.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Pedro E. Martinez, M.D., Principal Investigator
Organization: Behavioral Endocrinology Branch/National Institute of Mental Health/NIH
phone: 301-402-0615
e-mail: martinep@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00089414     History of Changes
Other Study ID Numbers: 040221
04-M-0221
First Submitted: August 4, 2004
First Posted: August 5, 2004
Results First Submitted: January 14, 2013
Results First Posted: January 2, 2017
Last Update Posted: August 25, 2017