International Journal of Gynecology and Obstetrics 114 (2011) 145148

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International Journal of Gynecology and Obstetrics

j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / i j g o

CLINICAL ARTICLE

Combined contraceptive ring versus combined oral contraceptive

(30-g ethinylestradiol and 3-mg drospirenone)
Ahmed M.M. Mohamed , Wael S.M. El-Sherbiny, Walaa A.I. Mostafa
Department of Obstetrics and Gynecology, Kasr Aini Hospital, Cairo University, Cairo, Egypt

a r t i c l e

i n f o

Article history:
Received 24 January 2011
Received in revised form 11 February 2011
Accepted 28 April 2011
Keywords:
Combined contraceptive vaginal ring
Combined oral contraceptive
Cycle control
Metabolic effects

a b s t r a c t
Objectives: To compare the adverse effects, cycle control, and metabolic effects of NuvaRing and a combined
oral contraceptive (COC). Methods: Women seeking contraception received NuvaRing (n = 300) or a COC
(n = 300) for 12 cycles in a randomized, open-label trial. Results: The total number of women with adverse
effects did not differ signicantly between the 2 groups. Leucorrhea, vaginitis, decreased libido, and ringrelated problems were more common with NuvaRing, whereas weight increase, acne, and emotional lability
were more common with the COC. Breakthrough bleeding occurred in 11.3% of women receiving NuvaRing
and in 14.7% of women receiving the COC; 2.1% and 2.9% of women, respectively, had no withdrawal bleeding.
Differences in blood pressure, blood sugar levels, lipid prole, liver enzyme activity, and anticoagulant activity
were not statistically signicant, with the exception of low-density lipoprotein levels measured at 6 and
12 months, which were signicantly lower in the NuvaRing group than in the COC group. Conclusions:
NuvaRing is a good alternative to a COC. It is associated with a slightly reduced incidence of breakthrough
bleeding and there were no clinically relevant adverse effects or changes in blood pressure, blood sugar levels,
lipid prole, or anticoagulant activity when compared with the COC.
2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

1. Introduction
Combined oral contraceptives (COC) are a well-established
method of contraception with proven efcacy and have been available
for over 40 years [1]. Since their introduction, however, oral
contraceptives have undergone extensive study, continual development, and signicant improvements. Unlike the original oral
contraceptives, new low-dose oral contraceptives have few health
risks when used by properly selected women and many health
benets [2]. However, reducing the dose of estrogen can compromise
cycle control, which is a key factor affecting contraceptive acceptability, compliance, and convenience [3]. The adverse effects of oral
contraceptives include breast tenderness, nausea, headache, mood
changes, and bloating [4].
In development for more than 20 years, the rst vaginal ring
contraceptive, NuvaRing (Merck, Whitehouse Station, NJ, USA), was
approved by the Food and Drug Administration in 2001 and brought
to market in 2002. Like oral contraceptive pills, the ring provides a
safe, effective, and rapidly reversible method of contraception. It
offers the lowest estrogen dose of any estrogenprogestin contraceptive product [5].
NuvaRing is a exible combined hormonal contraceptive ring that
releases 15 g of ethinylestradiol (EE) and 120 g of etonogestrel per
Corresponding author at: 135 King Faisal Street, Haram, Giza 12151, Egypt.
Tel.: + 20 2 0105227404; fax: + 20 2 35873103.
E-mail address: prof.ahmedmaged@gmail.com (A.M.M. Mohamed).

day over a 24-hour period. It is intended for use over a period of

3 weeks per cycle. The hormone release remains steady even if its use
is extended to up to 28 days. Unlike with oral contraceptives, there are
no daily uctuations in hormone levels. The placement of the ring is
limited only by comfort issues because hormone release occurs
anywhere in the vagina [4]. Absorption of the 2 steroid hormones
through the vagina is rapid, with therapeutic levels of EE and
etonogestrel being reached during the rst day of use. The half-life
is 20 hours for EE and 22 hours for etonogestrel [6].
The advantages of the contraceptive ring include its once-a-month
dosing schedule, the fact that it is discreet and its presence can be
detected only by a clinician or intimate partner, the rapid reversibility
of its contraceptive effects, and its high efcacy even in overweight
women [7]. In addition, NuvaRing has the lowest estrogen dose of any
combination hormonal contraceptive, it offers excellent control of
unscheduled breakthrough bleeding and spotting from the start, it
continues to offer contraceptive protection for an extra week in
women who forget to remove the ring on day 21, it can be removed
for up to 3 hours per day, it reduces dysmenorrhea [8], and it
encourages colonization of the vagina with hydrogen-peroxideproducing lactobacilli [9].
The adverse effects of the ring are similar to those seen with lowdose oral contraceptives, except for the fact that 2.6% of users
experience device-related events such as ring expulsion, foreign body
sensation, or coital problems [10].
The primary aims of the present study were to compare NuvaRing
with a COC containing 30 g of EE and 3 mg of drospirenone in terms

0020-7292/$ see front matter 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.ijgo.2011.03.008

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A.M.M. Mohamed et al. / International Journal of Gynecology and Obstetrics 114 (2011) 145148

of adverse effects, cycle control, blood pressure changes, and effects

on metabolic parameters.

2. Material and methods

The present randomized, open-label study included women who
attended the contraception clinic at Kasr El-Aini Hospital in Cairo,
Egypt, between May 1, 2008, and July 31, 2010. The study was
approved by the local Ethics Committee and informed consent was
obtained from all participants.
The 600 women included in the present study were 1742 years of
age, had regular menstrual cycles, were at risk of becoming pregnant,
and sought contraception. Exclusion criteria included contraindications for contraceptive steroid use, the use of an injectable hormonal
contraceptive 6 months prior to study initiation, use of a hormonemedicated intrauterine device or any other hormonal contraceptive
within 2 months prior to the study begin, and abortion or breastfeeding within 2 months before starting the trial medication. Women with
an abnormal cervical smear diagnosed during screening and those
with a prolapse of the uterine cervix, cystocele, and/or rectocele
diagnosed before or during screening were also excluded.
The participants received treatment for 12 consecutive cycles. Each
treatment cycle consisted of 3 weeks of ring/pill treatment followed
by a 1-week ring-free/pill-free period. The women were randomized
in a 1:1 ratio to receive the NuvaRing (NV Organon, Oss, The
Netherlands) or a COC containing 30 g of EE and 3 mg of
drospirenone (Yasmin; Schering AG, Berlin, Germany). On entry

Subjects
randomized and
treated (n=600)

into the study, the women in the NuvaRing group received

instructions on how and when to insert and remove the ring.
The women were seen 5 times: At a screening visit and within
1 week after the ring-free/pill-free periods of cycles 3, 6, 9, and 12 or at
premature discontinuation. At the initial screening visit, all women were
fully informed of the nature of the study. They then provided a medical
and gynecologic history and documentation of a Pap result obtained
within the past 12 months. Blood pressure, height, and weight were
recorded at all 5 study visits and the body mass index was calculated.
At each study visit, the clinical adverse eventsreported by the
patients during their medical or gynecologic evaluation or observed by
the physician during the examinationwere recorded. Particular attention was paid to blood pressure, acne, body weight, and vaginal discharge.
Diary cards were issued at screening and used for the daily
documentation of vaginal bleeding patterns up to and including the
ring-free/pill-free period of cycle 12. Withdrawal bleeding was
dened as bleeding or spotting that occurred during the ring-free/
pill-free period, with early withdrawal bleeding starting before and
continuing into the ring-free/pill-free period and late withdrawal
bleeding persisting after the ring-free/pill-free period. Breakthrough
bleeding/spotting was dened as any bleeding or spotting that
occurred during the periods of ring/pill use. It was classied as early
if occurring during the rst 10 days, midcycle if occurring on the 11th
day, and late if occurring during the last 10 days of ring or pill use.
Blood parameters, including blood sugar level, lipid prole, liver
enzyme activity, and anticoagulant activity, were measured at the
screening visit (within 2 weeks before the beginning of ring or pill
use) and during the last week of ring or pill use in cycles 3, 6, 9, and 12.
Women refrained from smoking and alcohol for at least 12 hours and
from food for at least 8 hours before the blood tests.
The results were compared by using a 1-way analysis of variance
(ANOVA) and the Scheff multiple comparison test. Statistical analysis
was performed using SPSS 10 (SPSS, Chicago, IL, USA). P b 0.05 was
considered statistically signicant.
3. Results

NuvaRing
(n=300)

COC
(n=300)

After 3 months
(n=263)

After 3 months
(n=270)

After 6 months
(n=248)

After 6 months
(n=259)

After 9 months
(n=244)

After 9 months
(n=251)

In total, 600 women were randomly divided into 2 groups, with

300 women per group at the beginning of treatment (Fig. 1). The
number of women in the NuvaRing group declined to 263, 248, 244,
and 239 at 3, 6, 9, and 12 months, respectively; 27 (9.0%) women
discontinued treatment because of adverse effects and 2 (0.7%)
women because they wished to become pregnant; 32 women were
lost to follow-up. The number of women in the COC group declined to
270, 259, 251, and 245 at 3, 6, 9, and 12 months. Treatment was
discontinued by 17 (56.7%) women because of adverse effects and by
3 (1.0%) women because they wished to become pregnant; 2 (0.7%)
women dropped out because they became pregnant and 33 (11.0)
were lost to follow-up. There were no signicant differences in age,
parity, and body mass index between the 2 study groups at baseline
(Table 1).
Certain adverse effects such as nausea, vomiting, headache,
mastalgia, and dysmenorrhea occurred with similar frequencies in
both study groups (Table 2). Leucorrhea, vaginitis, decreased libido,
and ring-related problems (discomfort, sensation of the ring by the
Table 1
Demographic data at baseline.a
Parameter

After 12 months
(n=239)

After 12 months
(n=245)

Fig. 1. Flow chart of the participants.

Age, y
Parity
Body mass index

NuvaRing
(n = 300)

Combined oral contraceptive

(n = 300)

29.7 4.1
2.9 0.9
27.3 2.5

30.9 4.2
3.4 1.1
25.9 2.3

a
Values are given as mean SD. The differences between NuvaRing and the
combined oral contraceptive were not statistically signicant.
b
Calculated as weight in kilograms divided by the square of height in meters.

A.M.M. Mohamed et al. / International Journal of Gynecology and Obstetrics 114 (2011) 145148
Table 2
Drug-related adverse effects.a

Table 4
Blood pressure effects.a

Adverse effect

NuvaRing
(n = 239)

Combined oral contraceptive

(n = 245)

Blood pressure
parameter

Nausea
Vomiting
Leucorrhea
Vaginitis
Headache
Mastalgia
Weight increase
Acne
Decreased libido
Emotional lability
Dysmenorrhea
Ring-related problems
Total number of women
experiencing adverse effects

7 (2.9)
1 (0.4)
10 (4.2) b
11 (4.6) b
19 (7.9)
8 (3.3)
4 (1.7) b
1 (0.4) b
8 (3.3) b
1 (0.4) b
7 (2.9)
16 (6.7) b
79 (33.1)

11 (4.5)
3 (1.2)
2 (0.8)
3 (1.2)
17 (6.9)
6 (2.4)
11 (4.5)
12 (4.9)
2 (0.8)
11 (4.5)
3 (1.2)
0 (0.0)
70 (28.6)

Systolic blood pressure

NuvaRing
114.6 10.7
Combined oral
117.3 10.9
contraceptive
Diastolic blood pressure
NuvaRing
72.4 9.1
Combined oral
71.5 8.1
contraceptive

a
b

Values are given as number (percentage).

P b 0.05 for the difference between NuvaRing and the combined oral contraceptive.

woman or her partner during intercourse, difculties with ring

insertion and removal) were more common in the NuvaRing group,
whereas weight increase, acne, and emotional lability were more
common in the COC group. The difference in the total number of
women who had adverse effects (79 in the NuvaRing group versus 70
in the COC group) was not statistically signicant.
The number of women with breakthrough bleeding, especially
early breakthrough bleeding, was lower in the NuvaRing group than
in the COC group (11.3% and 14.7%, respectively; P b 0.05; Table 3). The
frequencies of midcycle bleeding (NuvaRing, n = 4; COC, n = 5) and
late breakthrough bleeding (NuvaRing, n = 9; COC, n = 13) were not
signicantly different. Absence of withdrawal bleeding, early withdrawal bleeding, and late withdrawal bleeding occurred with similar
frequencies in the 2 groups.
The groups did not differ signicantly at any time point in terms of
blood pressure (Table 4) and blood tests results (Table 5). Exceptions
were the levels of low-density lipoprotein (LDL) at 6 and 12 months,
which were signicantly lower in the NuvaRing group than in the COC
group (Table 5).
4. Discussion
The results of the present randomized, open-label trial demonstrate that NuvaRing is a reasonable alternative means of hormonal
contraception when compared with a COC containing 30 g of EE and
3 mg of drospirenone.
In the present study, the total number of women experiencing
adverse effects was similar with NuvaRing and with the COC. Most of
the adverse effects related to systemic steroid use, such as weight
increase, acne, and emotional lability, were more common in the COC
group, whereas local adverse effects such as leucorrhea, vaginitis, and
ring-related problems were more common in the NuvaRing group.
Table 3
Bleeding pattern and cycle control.a
Parameter
Breakthrough bleeding
No
Early
Midcycle
Late
Withdrawal bleeding
No
Early
Late

147

NuvaRing
(n = 239)

Combined oral contraceptive

(n = 245)

212 (88.7)
14 (5.9)
4 (1.7)
9 (3.8)

209
18
5
13

5 (2.1)
26 (10.9)
14 (5.9)

(85.3)
(7.3)
(2.0)
(5.3)

7 (2.9)
19 (7.8)
16 (6.5)

a
Values are given as number (percentage). The differences between NuvaRing and
the combined oral contraceptive were not statistically signicant.

Baseline

3 months

6 months

12 months

114.3 10.7 113.9 10.4 114.4 10.6

125.4 13.1 125.6 12.9 126.2 13.2

71.7 8.4
78.5 9.9

73.2 8.2
81.5 10.1

71.8 8.4
79.7 10.3

a
Values are given as mean SD. The differences between NuvaRing and the
combined oral contraceptive were not statistically signicant.

Two noncomparative studies [5,11] found that the incidence of

estrogen-related adverse effects, such as breast tenderness, headache,
and nausea, was low among women using NuvaRing. This agrees with
the observation that the systemic exposure to EE is approximately 50%
lower with NuvaRing (releasing 15 g EE per day) than with a COC
containing 30 g EE per pill [12]. However, 2 randomized controlled
trials [13,14] found that the incidence of estrogen-related adverse
effects was not signicantly lower with NuvaRing than with a COC.
In agreement with the present ndings, Ahrendt et al. [13]
reported that the incidences of local adverse effects such as
leucorrhea, vaginal discomfort, vaginitis, and ring-related adverse
effects comprising foreign body sensation, coital problems, and
expulsions are higher with NuvaRing than with a COC.

Table 5
Effects on blood parameters.a
Baseline
FBS, mg/dL
NuvaRing
COC
PPBS, mg/dL
NuvaRing
COC
Triglycerides, mg/dl
NuvaRing
COC
Cholesterol, mg/dl
NuvaRing
COC
HDL, mg/dl
NuvaRing
COC
LDL, mg/dl
NuvaRing
COC
AST, IU/l
NuvaRing
COC
ALT, IU/l
NuvaRing
COC
Antithrombin III
activity, %
NuvaRing
COC
Protein C (APCR) c
NuvaRing
COC

3 months

6 months

12 months

87.9 10.9
90.2 11.8

92.3 10.8
98.3 12.1

93.1 11.7
101.2 12.2

94.1 11.8
99.7 12.2

99.9 12.3
102.4 12.7

106.4 12.5
118.6 13.3

104.5 13.1
116.3 12.9

101.4 11.7
116.5 12.7

86.1 7.3
85.6 6.8

101.6 12.8
103.6 13.4

99.2 10.6
99.5 9.7

99.7 10.9
100.1 11.8

179.6 8.9
184.3 11.4

169.5 8.6
179.3 10.9

171.2 9.1
175.4 9.9

172.2 8.7
177.8 10.8

62.6 2.9
61.1 2.7

64.1 2.8
62.1 2.8

64.2 3.2
61.6 2.4

64.4 3.1
63.2 2.9

102.4 10.3
110.3 9.6

98.1 10.1
109.9 9.6

95.2 8.7 b
119.8 11.6

94.8 8.3 b
121.3 11.8

23.1 7.1
20.3 5.7

22.3 6.4
21.2 5.7

22.2 6.1
22.4 6.3

21.2 5.8
21.3 5.9

19.8 5.7
18.2 6.2

18.8 5.7
18.3 6.4

17.9 6.2
17.6 7.1

17.7 5.8
18.2 7.2

103.8 11.9
100.1 11.8

87.3 10.8
85.2 10.8

86.2 10.7
82.1 10.9

86.1 10.8
84.4 11.2

2.32 0.15
2.23 0.12

2.12 0.13
2.09 0.12

2.12 0.11
1.99 0.11

2.14 0.11
2.03 0.09

Abbreviations: ALT, alanine aminotransferase; APCR, activated protein C resistance;

aPTT, activated partial prothrombin time; AST, aspartate aminotransferase; COC,
combined oral contraceptive; FBS, fasting blood sugar; HDL, high-density lipoprotein;
LDL, low-density lipoprotein; PPBS, postprandial blood sugar.
a
Values are given as mean SD.
b
P b 0.05 for the difference between NuvaRing and the combined oral contraceptive.
c
APCR is a ratio between aPTT with APC (seconds) and aPTT (seconds).

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A.M.M. Mohamed et al. / International Journal of Gynecology and Obstetrics 114 (2011) 145148

A normal bleeding pattern and good cycle control are key factors
inuencing compliance and acceptability. Breakthrough bleeding
tended to occur less frequently in the NuvaRing group, as expected,
but the number studied was too small to conrm a statistically
signicant reduction. More studies are required to evaluate this issue.
The low incidence of breakthrough bleeding with NuvaRing may be
explained by NuvaRing's continuous release of contraceptive hormones,
which is in contrast to the situation with COCs, where the circulating
concentrations of contraceptive hormones uctuate on a daily basis. The
withdrawal bleeding patterns were similar in both groups.
Two previous 1-year, open-label, noncomparative studies conducted at 52 centers in Europe [11] and 48 centers in North America
[12] evaluated bleeding patterns in women using NuvaRing. A
combined analysis of the data for the per-protocol populations of
the 2 studies revealed that 98.5% (95% condence interval [CI] 97.7%
99.0%) of women had withdrawal bleeding; early withdrawal
bleeding occurred in 6.1% (95% CI 5.1%8.4%) of women and late
withdrawal bleeding occurred in 23.9% (95% CI 20.5%26.5%) of
women [15]. In most women, early or late withdrawal bleeding was
restricted to spotting only [15].
In the present study, differences between the groups in terms of
the systolic and diastolic blood pressure were statistically nonsignificant throughout the whole study period. In the previously mentioned
noncomparative studies [5,11], no clinically relevant blood pressure
changes from baseline were observed either. Similarly, the blood
pressure did not change signicantly from baseline in either NuvaRing
users or COC users in most randomized studies [9,13,14,1618]. One
study [17] reported hypertension in 4 women (0.8%) in the NuvaRing
group and in 8 (1.5%) women in the COC group.
The levels of fasting and postprandial blood glucose, triglycerides,
high-density lipoprotein (HDL), cholesterol, alanine aminotransferase, aspartate aminotransferase, and antithrombin, and the activity of
protein C in the present study were not signicantly different
between the NuvaRing and COC groups at 3, 6, 9, and 12 months.
However, the levels of LDL measured at 6 and 12 months were
signicantly lower in the NuvaRing group than in the COC group.
In a previous study [19], blood lipids were measured at baseline and
after 3 and 6 months of using NuvaRing or a COC containing 30 mg EE
and 150 mg levonorgestrel. In the COC group, HDL levels were
decreased and LDL levels were increased compared with baseline at
cycle 6. In the NuvaRing group, HDL and LDL levels did not change
signicantly by cycle 6. The triglyceride levels, however, increased by
24% in the NuvaRing group, compared with a 9% increase among COC
users. These changes are probably related to the decreased androgenicity of etonogestrel compared with levonorgestrel.
An open-label, nonrandomized study [20] compared changes in
hemostatic variables during the use of NuvaRing (n = 44) or an oral
contraceptive containing 150 g of levonorgestrel and 30 g of EE
(n = 43) for 6 cycles. The majority of the assessed anticoagulation and
brinolytic variables were comparable between the 2 groups.
However, the antithrombin and protein C activities tended to be
higher with NuvaRing. There were no signicant differences in brin
turnover between the treatment groups. The data show that both
NuvaRing and oral contraceptives containing levonorgestrel and EE
are associated with minimal effects on hemostatic variables.
In conclusion, NuvaRing is a good alternative to a COC. The
incidence of breakthrough bleeding was slightly reduced with

NuvaRing and cycle control slightly improved. There were no

clinically relevant adverse effects or changes in blood pressure,
blood sugar levels, serum lipids, and anticoagulant activity compared
with a COC containing 30 g of EE and 3 mg of drospirenone.

Conict of interest
The authors have no conicts of interest.

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