NOMAC-E2 compares to LNG combined oral contraceptives in women over forty: real-world PRO-E2 study

Figures & data

Table 1. Regional distribution (country) of women over 40 years at study entry by user cohort.

	NOMAC-E2	COCLNG	Total
Number (%) of women	7,762 (100%)	6,059 (100%)	13,821 (100%)
Europe
Germany	184 (2.4%)	239 (3.9%)	423 (3.1%)
Spain	595 (7.7%)	329 (5.4%)	924 (6.7%)
Austria	16 (0.2%)	17 (0.3%)	33 (0.2%)
France	28 (0.4%)	11 (0.2%)	39 (0.3%)
Italy	2,717 (35.0%)	1,656 (27.3%)	4,373 (31.6%)
Poland	494 (6.4%)	421 (6.9%)	915 (6.6%)
Sweden	4 (0.05%)	4 (0.07%)	8 (0.06%)
Russia	3,161 (40.7%)	2,807 (46.3%)	5,968 (43.2%)
Hungary	441 (5.7%)	320 (5.3%)	761 (5.5%)
Australia	18 (0.2%)	14 (0.2%)	32 (0.2%)
Colombia	104 (1.3%)	241 (4.0%)	345 (2.5%)

Table 2. Selected baseline characteristics of women over 40 years by user cohort.

	NOMAC-E2	COCLNG	Total
Number (%) of women	7,762 (56.2)	6,059 (43.8)	13,821 (100)
WY (%)	8,525 (40.1)	6,764 (31.8)	21,241* (100)
Weight (kg)
Mean (SD)	66.3 (11.62)	66.9 (11.98)	66.6 (11.78)
BMI (kg/m^2)
Mean (SD)	24.4 (4.08)	24.7 (4.29)	24.6 (4.18)
Current smoker, n (%)	1,263 (16.3)	1,017 (16.8)	2,280 (16.5)
Heavy smoker (>15 cigarettes per day)	213 (2.7)	150 (2.5)	363 (2.6)
High blood pressure (treated), n (%)	240 (3.1)	189 (3.1)	429 (3.1)
Deep venous thrombosis (DVT), n (%)	19 (0.2)	12 (0.2)	31 (0.2)
Pulmonary embolism (PE), n (%)	1 (0.01)	2 (0.03)	3 (0.02)
Myocardial infarction (MI), n (%)	1 (0.01)	7 (0.1)	8 (0.06)
Stroke, n (%)	3 (0.04)	2 (0.03)	5 (0.04)
Family history of VTE (DVT or PE), n (%)	314 (4.0)	228 (3.8)	542 (3.9)
Ever been pregnant (gravidity), n (%)	6,645 (85.6)	5,455 (90.0)	12,100 (87.5)
Thereof at least one live birth (parity), n (%)	6,465 (97.3)	5,310 (97.3)	11,775 (97.3)
Reasons for COC prescription at study entry, n (%)
Contraception only	3,380 (43.5)	2,901 (47.9)	6,281 (45.4)
Contraceptive and/or non-contraceptive reasons	4,226 (54.4)	3,056 (50.4)	7,282 (52.7)
Thereof cycle regulation, n (%)	1,837 (43.5)	1,408 (46.1)	3,245 (44.6)
Thereof painful menstrual bleeding, n (%)	968 (22.9)	686 (22.4)	1,654 (22.7)
Thereof heavy and/or prolonged menstrual bleeding, n (%)	1,524 (36.1)	983 (32.2)	2,507 (34.4)
Non-contraceptive reasons only	1,384 (17.8)	958 (15.8)	2,342 (16.9)
Education level, n (%)
Less than university entrance level	1,045 (13.5)	1,143 (18.9)	2,188 (15.8)
University entrance level	3,391 (43.7)	2,643 (43.6)	6,034 (43.7)
More than university entrance level	3,311 (42.7)	2,261 (37.3)	5,572 (40.3)
Depression requiring treatment, n (%)	296 (3.8)	194 (3.2)	490 (3.5)

Note: Data privacy regulations in Germany restricted the capture of date of birth information to the year of birth only. The day and month of birth for patients in that country were set to 1st July.

*Describes WY from the whole study population, including women who stopped using hormonal contraceptives (ex-use) or switched to other contraceptives during the follow-up period

Figure 1. (a) Incidence rates of VTE (deep venous thrombosis of the lower extremities and pulmonary embolism) by user cohort and (b) Contraceptive failure rates by user cohort.

Figure 2. (a) Change in weight after study entry by user cohort and (b) Change in mood score after study entry by user cohort.