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Relationship Between the Menstrual Cycle and Heart Disease in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01546454
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : October 23, 2014
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
Medical Research Foundation, Oregon
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Coronary Heart Disease
Interventions Drug: Ethinyl Estradiol-Levonorgestrel combination
Drug: leuprolide acetate
Drug: Estradiol
Drug: Progesterone
Enrollment 5
Recruitment Details  
Pre-assignment Details One enrolled participant was lost to follow-up prior to receiving any interventions.
Arm/Group Title All Study Participants
Hide Arm/Group Description [Not Specified]
Period Title: Natural Menstrual Cycle
Started 4
Completed 4
Not Completed 0
Period Title: Oral Contraceptive Cycle
Started 4
Completed 4
Not Completed 0
Period Title: Eligard Treatment
Started 4
Completed 4
Not Completed 0
Period Title: Estrogen/Progesterone Replacement Cycle
Started 4
Completed 4
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Healthy premenopausal women from the Portland, OR metro area
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Total to HDL Cholesterol Ratio
Hide Description [Not Specified]
Time Frame Entire Study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-steroidal Effects Contraceptive Effects Steroid Effects
Hide Arm/Group Description:

Natural menstrual cycle versus Estrogen/Progesterone replacement cycle. Interventions include leuprolide acetate to induce hypogonadism and estradiol and progesterone to replace hormone levels.

leuprolide acetate: single 22.5 mg subcutaneous depot suspension

Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days

Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days

Oral contraceptive cycle versus Eligard treatment. Interventions include ethinyl estradiol-levonorgestrel combination and leuprolide acetate.

Ethinyl Estradiol-Levonorgestrel combination: 0.03 mg ethinyl estradiol, 0.15 mg levonorgestrel oral daily for 21 days

leuprolide acetate: single 22.5 mg subcutaneous depot suspension

Estrogen/Progesterone replacement cycle versus Eligard treatment. Interventions include leuprolide acetate, estradiol, and progesterone.

leuprolide acetate: single 22.5 mg subcutaneous depot suspension

Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days

Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days

Overall Number of Participants Analyzed 4 4 4
Mean (95% Confidence Interval)
Unit of Measure: Total to HDL Cholesterol Ratio
0.146
(0.033 to 0.26)
0.148
(-0.13 to 0.43)
-0.89
(-2.09 to 0.315)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/4 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Randy Bogan
Organization: University of Arizona
Phone: 520-621-1487
EMail: boganr@email.arizona.edu
Layout table for additonal information
Responsible Party: Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01546454    
Other Study ID Numbers: IRB8023
First Submitted: February 22, 2012
First Posted: March 7, 2012
Results First Submitted: April 11, 2014
Results First Posted: October 23, 2014
Last Update Posted: March 22, 2017