Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Mirena and Estrogen for Control of Perimenopause Symptoms and Ovulation Suppression

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01613131
First received: June 4, 2012
Last updated: October 29, 2015
Last verified: October 2015
Results First Received: August 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Menopausal and Other Perimenopausal Disorders
Interventions: Drug: Mirena
Drug: Estradiol
Drug: Placebo Gel

  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
Women were recruited from the University of Colorado Denver campus by direct physician referral or from advertisements in the University community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Women using systemic hormonal contraception (patch, pill, ring) were required to have a 30 day hormone washout prior to placement. One subject signed the consent, but failed to meet the inclusion/exclusion criteria during the screening process. Thus, there were 39 women that were enrolled, but only 38 that started in the participant flow.

Reporting Groups
  Description
Mirena + Estradiol Gel

Subjects will be assigned to use of Estradiol gel for use with Mirena.

Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).

Estradiol: Topical, .06%, Applied once daily for 50 days.

Mirena + Placebo Gel

Subjects will be assigned to use of placebo gel for use with Mirena.

Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).

Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator.


Participant Flow:   Overall Study
    Mirena + Estradiol Gel     Mirena + Placebo Gel  
STARTED     20     18  
COMPLETED     17     13  
NOT COMPLETED     3     5  
Withdrawal by Subject                 3                 5  



  Baseline Characteristics
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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
Mirena + Estradiol Gel

Subjects will be assigned to use of Estradiol gel for use with Mirena.

Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).

Estradiol: Topical, .06%, Applied once daily for 50 days.

Mirena + Placebo Gel

Subjects will be assigned to use of placebo gel for use with Mirena.

Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).

Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator.

Total Total of all reporting groups

Baseline Measures
    Mirena + Estradiol Gel     Mirena + Placebo Gel     Total  
Number of Participants  
[units: participants]
  20     18     38  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     18     38  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     20     18     38  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     20     18     38  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hot Flashes   [ Time Frame: Day 0 ]

2.  Primary:   Sleep   [ Time Frame: Day 0 ]

3.  Primary:   Depression   [ Time Frame: Day 0 ]

4.  Primary:   Fatigue   [ Time Frame: Day 0 ]

5.  Primary:   Sleep   [ Time Frame: Day 90 ]

6.  Primary:   Sleep   [ Time Frame: Day 140 ]

7.  Primary:   Hot Flashes   [ Time Frame: Day 90 ]

8.  Primary:   Hot Flashes   [ Time Frame: Day 140 ]

9.  Primary:   Depression   [ Time Frame: Day 90 ]

10.  Primary:   Depression   [ Time Frame: Day 140 ]

11.  Primary:   Fatigue   [ Time Frame: Day 90 ]

12.  Primary:   Fatigue   [ Time Frame: Day 140 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The main limitation was the sample size, which is consistent with a pilot study, and which can only inform the design of future research.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Chanel Mansfield
Organization: University of Colorado Denver
phone: 303-724-6501
e-mail: chanel.mansfield@ucdenver.edu



Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01613131     History of Changes
Other Study ID Numbers: 11-1711
Study First Received: June 4, 2012
Results First Received: August 11, 2015
Last Updated: October 29, 2015
Health Authority: United States: Institutional Review Board