Trial Outcomes & Findings for Relationship Between the Menstrual Cycle and Heart Disease in Women (NCT NCT01546454)

Last Updated: 2017-03-22

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Entire Study

Results posted on

2017-03-22

One enrolled participant was lost to follow-up prior to receiving any interventions.

Participant milestones
Measure	All Study Participants
Natural Menstrual Cycle STARTED	4
Natural Menstrual Cycle COMPLETED	4
Natural Menstrual Cycle NOT COMPLETED	0
Oral Contraceptive Cycle STARTED	4
Oral Contraceptive Cycle COMPLETED	4
Oral Contraceptive Cycle NOT COMPLETED	0
Eligard Treatment STARTED	4
Eligard Treatment COMPLETED	4
Eligard Treatment NOT COMPLETED	0
Estrogen/Progesterone Replacement Cycle STARTED	4
Estrogen/Progesterone Replacement Cycle COMPLETED	4
Estrogen/Progesterone Replacement Cycle NOT COMPLETED	0

Withdrawal data not reported

Relationship Between the Menstrual Cycle and Heart Disease in Women

Baseline characteristics by cohort
Measure	All Study Participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

Timeframe: Entire Study

Outcome measures
Measure	Non-steroidal Effects n=4 Participants 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	Contraceptive Effects n=4 Participants 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	Steroid Effects n=4 Participants 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
Total to HDL Cholesterol Ratio	0.146 Total to HDL Cholesterol Ratio Interval 0.033 to 0.26	0.148 Total to HDL Cholesterol Ratio Interval -0.13 to 0.43	-0.89 Total to HDL Cholesterol Ratio Interval -2.09 to 0.315

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Arizona

Phone: 520-621-1487