Continuation rates, bleeding profile acceptability, and satisfaction of women using an oral contraceptive pill containing estradiol valerate and dienogest versus a progestogen-only pill after switching from an ethinylestradiol-containing pill in a real-life setting: results of the CONTENT study

Figures & data

Table 1 Baseline demographic characteristics

Variable	Total (N=3,150)		E2 V/DNG (n=2,558)		POP (n=592)
	n	%	n	%	n	%
Age (years)
18–25	706	22.4	572	22.4	134	22.6
26–34	1,034	32.8	850	33.2	184	31.1
35–50	1,215	38.6	994	38.9	221	37.3
BMI (mg/kg^2)
<18.5	169	5.4	141	5.5	28	4.7
18.5 to <25	2,281	72.4	1,872	73.2	409	69.1
26 to <30	492	15.6	398	15.6	94	15.9
>30	144	4.5	102	4.0	42	7.1
Educational level
Primary school	85	2.7	60	2.3	25	4.2
Higher than primary school	3,046	96.7	2,483	97.1	563	95.1
Smoking status
No	2,543	80.7	2,129	83.2	414	69.6
Yes	607	19.3	429	16.8	178	30.1

Abbreviations: BMI, body mass index; E₂V/DNG, estradiol valerate and dienogest; POP, progestogen-only pill.

Figure 1 Kaplan–Meier plot of duration until discontinuation due to unacceptable bleeding or other reasons (propensity score-adjusted population analysis).

Note: *Time to discontinuation for E₂V/DNG vs POP.
Abbreviations: E₂V/DNG, estradiol valerate and dienogest; POP, progestogen-only pill.

Figure 2 Bleeding profile changes at baseline and the last visit after switching to the E₂V/DNG pill or POP.

Notes: Proportion of women with (A) regular bleeding (once a month); (B) change from baseline in length of bleeding; (C) light/scanty bleeding; and (D) painless bleeding.
Abbreviations: E₂V/DNG, estradiol valerate and dienogest; POP, progestogen-only pill.

Figure 3 Percentage of women who rated their overall satisfaction as “satisfied” or “very satisfied” 3–5 months after switching to the E₂V/DNG pill or POP.

Abbreviations: E₂V/DNG, estradiol valerate and dienogest; POP, progestogen-only pill.

Figure S1 Percentage of women who rated their (A) physical or (B) emotional well-being as “better” or “much better” at their last visit after switching to the E₂V/DNG pill or POP.

Abbreviations: E₂V/DNG, estradiol valerate and dienogest; POP, progestogen-only pill.

Table S1 Ethics committees and institutional review boards that approved the study

Country	Reviewing board
Czech Republic	• State Institute for Drug Control (SUKL)
France	• Conseil Nacional de l’Ordre des Medicines
Germany	• Bundesinstitut für Arzneimittel und Medizinprodukte
	• GKV: Spitzenverband
	• KBV Kassenärztliche Bundesvereinigung
Greece	• National Drug Organization
	• General Hospital of Thessaloniki “PAPAGEORGIOU”. Hospital Scientific Committee
Hungary	• EGÉSZSÉGÜGYI TUDOMÁNYOS TANÁCS - Medical Research Council Scientific and Research Committee
Israel	• EC: Maccabi Healthcare
Italy	• EC: Azienda Ospebaliera Universitaria Policlinio Paolo Giaccone die Palermo
	• EC: Umberto I Policlinico die Roma
	• EC: Azienda Ospedaliero Universitaria, Santa Maria de la Misericordia di Udine
	• EC: Azienda Ospedaliero die Rilievo Nazionale e die alta Specializzazione “Garibaldi”
	• EC: Universita di ferra, Servicio sanitario regionale Emilia Ramagna
	• EC: Universitaria degli Studi die Napoli “FedericoII”
	• EC: Azienda Ospedaliero, San Gerardo
Russia	• EC: Interuniversity ethic committee
	• Ministry of Health
Slovakia	• SAFS: Slovenská asociácia farmaceutických spoločností orientovaných na výskum a vývoj
	• State Institute for Drug Control SUKL
	• EC: Ustredna Eticka komisia Bratislaveskeho samospravneho kraja
Sweden	• EC: Regionala etikprövningsnämnden i Uppsala
	• Medical Product agency
Great Britain	• National Research Ethics Service
	• Sussex NHS Research Consortium
	• NHS Berkshire East
	• NHS Leeds
	• Liverpool NHS
	• NHS: Comprehensive Local Research Network for Kent and Medway
	• NHS York Hospitals

Table S2 Bleeding pattern during the preceding 3 months before enrollment (baseline visit, efficacy population)

Bleeding pattern parameters	Total (N=3,150)		E2 V/DNG (n=2,558)		POP (n=592)
	n	%	n	%	n	%
Regularity of withdrawal bleeding
Regular (once a month)	2,680	85.1	2,177	85.1	503	85.0
Occasionally absent	426	13.5	351	13.7	75	12.7
Amenorrhea	38	1.2	25	1.0	13	2.2
Maximum length of bleeding (days)
1–2	302	9.7	239	9.5	63	10.9
3–5	2,055	66.2	1,653	65.4	402	69.6
6–7	615	19.8	523	20.7	92	15.9
≥8	126	4.1	107	4.2	19	3.3
Maximum intensity of bleeding
Spotting	205	6.6	164	6.5	41	7.1
Light/scanty	681	21.9	541	21.4	140	24.2
Normal	1,703	54.8	1,397	55.3	306	52.9
Heavy	500	16.1	411	16.3	89	15.4
Painful bleeding
Yes	2,265	71.9	1,823	71.3	442	74.7
No	864	27.4	720	28.1	144	24.3
Intracyclic bleeding (more than once a month)
Yes	2,676	85.0	2,157	84.3	519	87.7
No	454	14.4	386	15.1	68	11.5

Abbreviations: E₂V/DNG, estradiol valerate and dienogest; POP, progestogen-only pill.

Table S3 Overview of TEAEs associated with E₂V/DNG and POP use

Type of event	Total (N=3,234)		E2 V/DNG (n=2,629)		POP (n=605)
	n	%	n	%	n	%
Overall adverse event rate	262	8.1	194	7.4	68	11.2
Drug-related adverse events	188	5.8	132	5.0	56	9.3
Serious adverse events
Nondrug related	3	0.1	3	0.1	0	0.0
Drug related	3	0.1	3	0.1	0	0.0
Deaths	0	0.0	0	0.0	0	0.0
Discontinuation
Nondrug related	179	5.5	132	5.0	47	7.8
Drug related	145	4.5	102	3.9	43	7.1

Abbreviations: E₂V/DNG, estradiol valerate and dienogest; POP, progestogen-only pill; TEAEs, treatment-emergent adverse events.