Treatment continuation and satisfaction in women using combined oral contraception with nomegestrol acetate and oestradiol: a multicentre, prospective cohort study (BOLERO)

Figures & data

Figure 1. Participant disposition. Reasons for discontinuation of NOMAC/E2 included treatment-related AEs, poor compliance, dissatisfaction and decision to change contraceptive method. Discontinuation of NOMAC/E2 that was not treatment-related included no longer needed contraception, scheduled surgery and desire for pregnancy.

Table 1. Demographic and clinical characteristics of women receiving NOMAC/E2 (N = 298).

Characteristic	Value
Age, years	29.2 ± 7.4
Age categories, years
≤25	102 (34.2)
26–30	87 (29.2)
31–35	53 (17.8)
36–40	24 (8.1)
>40	32 (10.7)
Race
Asian	2 (0.7)
Black	2 (0.7)
Caucasian	287 (96.3)
Hispanic	3 (1.0)
Other	4 (1.3)
Smoking, yes	53 (17.8)
Marital status
Single	206 (69.1)
Married	82 (27.5)
Divorced	10 (3.4)
Education
High school	140 (47.0)
Secondary school	38 (12.8)
University	120 (40.3)
Work status
Student	92 (30.9)
Employed	72 (24.2)
Housewife	20 (6.7)
Unemployed	24 (8.1)
Other	90 (30.2)
BMI, kg/m^2	21.5 ± 3.1
Systolic blood pressure, mmHg	111.6 ± 10.3
Diastolic blood pressure, mmHg	69.1 ± 7.7

Values are expressed as mean ± SD or n (%).

Table 2. Menstrual cycle and contraceptive method history of women receiving NOMAC/E2 (N = 298).

Medical history	Value
Age at menarche, years	12.4 ± 1.4
Cycle type, regular	223 (74.8)
Mean menstruation duration, days	4.9 ± 1.6
Prior pregnancy, yes	80 (26.8)
Prior abortion, yes	44 (14.8)
Use of previous contraception, yes	240 (80.5)
Method of previous contraception^a
COC	169 (56.7)
Barrier contraception	107 (35.9)
Natural contraceptive method	32 (10.7)
Reason for discontinuation of previous COC (n = 169)^a
No longer needed contraception (planning pregnancy or no partner)	34 (20.1)
Weight increase	27 (16.0)
Spotting	26 (15.4)
Headache	22 (13.0)
Reduced libido	10 (5.9)
Liquid retention/oedema	10 (5.9)
Poor compliance	9 (5.3)
Desired a different COC	7 (4.1)
Medical symptoms/physician recommendation	7 (4.1)
Acne	6 (3.6)
Vaginal dryness	5 (3.0)
Mood changes	3 (1.8)
Breast tension	2 (1.2)
Nausea	3 (1.8)
Poor efficacy	3 (1.8)
Desired different contraceptive method	2 (1.2)
Other^b	15 (8.9)

Values are expressed as mean ± SD or n (%).

^a Multiple responses allowed.

^b Other reasons included: participant decision without further explanation (n = 6), unknown (n = 6), amenorrhoea (n = 1), metrorrhagia (n = 1) and dysmenorrhoea (n = 1).

Figure 2. Probability of treatment continuation for 12 months among women receiving NOMAC/E2. The Kaplan–Meier discontinuation-free probability estimate from enrolment to day 365 was 73.7% (95% CI 68.0%, 78.5%). Censored women (n = 217) included treatment completers (n = 200) and women who discontinued for reasons not related to treatment (n = 17). Discontinuation events (n = 75) included women who discontinued treatment due to treatment-related AEs, poor compliance, dissatisfaction or decision to change contraceptive method (n = 51), and women lost to follow-up (n = 24).

Figure 3. Treatment satisfaction among women receiving NOMAC/E2.

Table 3. Change from enrolment in menstrual cycle-related symptoms of women receiving NOMAC/E2.

Variable	Total symptom score^a Mean ± SD	Change from enrolment 95% CI
Women completing the study (n = 200)
Enrolment	6.04 ± 4.32	–
Month 3	3.25 ± 3.05	−2.25, −3.40
Month 6	2.96 ± 3.13	−2.47, −3.59
Month 12	2.62 ± 2.74	−2.86, −3.98
Prior COC use (n = 116)
Enrolment	5.73 ± 4.05	–
Month 3	3.13 ± 3.08	−1.91, −3.44
Month 6	2.94 ± 3.04	−1.97, −3.43
Month 12	2.45 ± 2.80	−2.53, −4.03
No prior COC use (n = 84)
Enrolment	6.47 ± 4.67	–
Month 3	3.41 ± 3.04	−2.12, −3.93
Month 6	3.00 ± 3.25	−2.59, −4.35
Month 12	2.86 ± 2.65	−2.77, −4.46

^a Mixed model for repeated measures of change from enrolment in total symptom score, p < .0001. Total symptom score is the sum of the ratings of the individual symptoms on a 5 point scale ranging from absent to serious for menstrual cycle-related headache, breast pain/tenderness, swelling, dysmenorrhoea and mood disturbance.

Figure 4. Libido among women receiving NOMAC/E2.

Table 4. Treatment-related AEs reported by ≥2% of women receiving NOMAC/E2 (N = 292).

Treatment-related AE^a	n (%)
Metrorrhagia^b	39 (13.4)
Amenorrhoea	28 (9.6)
Headache	25 (8.6)
Drug withdrawal headache	1 (0.3)
Other headache/migraine	24 (8.2)
Abdominal distension	10 (3.4)
Breast discomfort or pain	8 (2.7)
Mood changes	7 (2.4)
Acne	6 (2.1)

^a Individual participants can be included in more than one treatment-related AE category.

^b The MedDRA preferred term metrorrhagia includes breakthrough bleeding and spotting.