The European Journal of Contraception & Reproductive

Health Care

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Femiject, a once-a-month combined injectable

contraceptive: experience from Pakistan

Rubina Izhar , Samia Husain , Muhammad Ahmad Tahir & Sonia Husain

To cite this article: Rubina Izhar , Samia Husain , Muhammad Ahmad Tahir & Sonia
Husain (2020): Femiject, a once-a-month combined injectable contraceptive: experience
from Pakistan, The European Journal of Contraception & Reproductive Health Care, DOI:
10.1080/13625187.2020.1799348

To link to this article: https://doi.org/10.1080/13625187.2020.1799348

Published online: 06 Aug 2020.

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THE EUROPEAN JOURNAL OF CONTRACEPTION & REPRODUCTIVE HEALTH CARE
https://doi.org/10.1080/13625187.2020.1799348

CLINICAL STUDY

Femiject, a once-a-month combined injectable contraceptive: experience

from Pakistan
Rubina Izhar, Samia Husain, Muhammad Ahmad Tahir and Sonia Husain
Department of Gynaecology and Obstetrics, Aziz Medical Centre, Karachi, Pakistan

ABSTRACT ARTICLE HISTORY

Objectives: The aims of the study were to compare the 12 month continuation rate, level of satis- Received 8 February 2020
faction and bleeding patterns of a once-a-month combined injectable contraceptive (CIC; Revised 30 June 2020
Femiject), a 3 monthly progestogen-only injectable contraceptive (depot medroxyprogesterone Accepted 18 July 2020
acetate [DMPA]) and combined oral contraceptives (COCs).
KEYWORDS
Methods: A prospective observational study was conducted at Aziz Medical Centre, Karachi, Bleeding pattern; combined
Pakistan. The study comprised 171 married women aged 19–35 years and requesting contracep- injectable contraceptive;
tion. Participants were offered injectable contraceptives or COCs and evaluated twice: once at the combined oral
beginning of the study and again after 12 months, or earlier if they discontinued use. contraceptives; continuation
Results: Sixty (35.1%) women chose COCs, 53 (31.0%) chose DMPA and 58 (33.9%) chose the CIC. rate; 3 monthly
The continuation rate was higher among CIC users (p ¼ .034). CIC users were more satisfied with progestogen-only injectable
their method compared with those who chose COCs or DMPA (63.8% vs 25.0% and 28.3%, respect- contraceptive; satisfaction
ively). Most CIC users said they were likely or very likely to use the method again (63.8%); only
25.9% said they would not recommend it to a friend. CIC users had, however, more spotting com-
pared with COC users (60.3% vs 3.3%; p ˂ .001).
Conclusion: As the continuation rate, level of satisfaction and bleeding profile of CIC users was
promising, increased uptake should be encouraged. Our study shows that CIC is a good option for
women requesting contraception.

Introduction
Pakistan is the sixth most populous country in the world
[1]. Contraceptive use is around 35% and only 26% use
modern methods. Injectable contraceptives are chosen by
almost 3% of contraceptive users. Around 45% of injectable
contraceptive users, however, report side effects; major
side effects include irregular menstrual periods (55%) [2].
Thus, an effective form of long-acting reversible contracep-
tion (LARC) is currently underused.
Combined oral contraceptives (COCs) provide good
menstrual cycle control [3]; however, women sometimes
forget to take their pill. According to a study in Saudi
Arabia, only 18% of women knew what to do after missing
more than two pills [4]. The need to take pills daily is cum-
bersome, which leads to dissatisfaction in many users [5].
Injectables achieve better compliance compared with
COCs. The most often used are 3 monthly progestogen-
only injectable contraceptives (POICs), of which depot
medroxyprogesterone acetate (DMPA) is the most widely
used formulation. However, women report abnormal bleed-
ing patterns with its use [6]. Combined injectable contra-
ceptives (CICs) address the disruption in bleeding patterns.
Oestrogen improves the cycle irregularity seen with POICs.
Compliance is also improved in comparison with COCs [7].
Once-a-month CICs produce bleeding patterns that are
acceptable and comparable to those of non-users [8]. A
Cochrane review reported that fewer women stopped
using CICs compared with POICs [9]. Most women who
want contraception are not happy with the methods avail-
able to them [10]. Non-compliant COC users may switch to
CICs after receiving adequate counselling. POIC users who
have no contraindication to combined preparations may
also use CICs. This approach can help them choose a
contraceptive that suits them better.
Greenstar Social Marketing is a private organisation in
Pakistan. It launched its low-cost contraception service
Sabz Sitara in 1995, which led to an improvement in avail-
ability of all contraceptive methods in the country. In 2010,
Femiject, a new CIC containing 50 mg norethisterone enan-
thate and 5 mg oestradiol valerate, was introduced to the
market; there is, however, a lack of data on its use. We
conducted this study to compare the continuation rates
with three contraceptive methods: the once monthly CIC
Femiject, the 3 monthly POIC DMPA, and COCs. We also
assessed levels of satisfaction and bleeding patterns with
all three methods.
Methods
A prospective observational study was conducted at Aziz
Medical Centre, Karachi. The study population comprised
women aged 19–35 years who requested contraception. A
non-probability consecutive sampling technique was used
to recruit women to the study. Women were eligible if
they were not pregnant or in the postpartum period and
only if they had regular, spontaneous menstrual cycles
(21–35 days). Women were excluded if they had any

CONTACT Samia Husain samiahusain_scorpio@hotmail.com Department of Gynaecology and Obstetrics, Aziz Medical Centre, B-151, Block W, Allama
Iqbal Town, North Nazimabad, Karachi 74600, Pakistan
ß 2020 The European Society of Contraception and Reproductive Health
2 R. IZHAR ET AL.
contraindications to hormonal contraceptive use; thus,
women older than 35 years or who smoked were excluded,
as were women with chronic hypertension, diabetes or a
history of alcohol or drug abuse. Women who had received
another injectable contraceptive 6 months prior to recruit-
ment were also excluded.
In Pakistan, women either use COCs or POICs. Pakistani
law forbids sex before marriage. As contraceptives are not
used by unmarried women, our sample comprised married
women only. Legal abortion is not available in Pakistan.
Women were offered all three studied methods of
contraception.
All women gave their written informed consent to par-
ticipate. Women who met the inclusion criteria were coun-
selled by trained health professionals and told about the
benefits of contraception. The methods available were
introduced in an unbiased manner. Emphasis was placed
on continuation of the method. Participants were thus
enabled to make an informed choice. Women who chose
COCs or a POIC were asked to take part in the study.
Consenting women were offered information leaflets.
Participants were divided into three groups: (1) COCs
(30 lg ethinylestradiol and 150 lg levonorgestrel); (2)
DMPA (a 3 monthly POIC containing 150 mg DMPA); and
(3) CIC (a once monthly CIC containing 50 mg norethister-
one enanthate and 5 mg oestradiol valerate). Women were
prescribed their chosen contraception; CIC and COC users
were advised to attend the clinic every month (COCs were
dispensed for 1 month at a time). Women were evaluated
twice: at the beginning of the study and at 12 months.
Those who stopped using contraception before 12 months
were evaluated at the time they stopped and were asked
about their reasons for discontinuation. A woman was
termed compliant if she did not stop her contraception.
For the purposes of the study, the participants were
included in the analysis only if they complied with fol-
low-up.
A pro forma was used to collect data. The first section
of the form collected data on participants’ sociodemo-
graphic characteristics. The second section included ques-
tions on their menstrual cycle. A separate section was
included to collect data on satisfaction with the chosen
method. Women answered three separate questions, based
on a Likert scale: (1) ‘Were you satisfied with your choice of
contraception?’ (1 ¼ very unsatisfied, 2 ¼ unsatisfied,
3 ¼ neutral, 4 ¼ satisfied, 5 ¼ very satisfied); (2) ‘Would you
use it again?’ (1 ¼ very unlikely, 2 ¼ unlikely, 3 ¼ neutral,
4 ¼ likely, 5 ¼ very likely); (3) ‘Would you recommend it to a
friend?’ (1 ¼ definitely no, 2 ¼ no, 3 ¼ neutral, 4 ¼ yes,
5 ¼ definitely yes). It was anticipated that this tool would
allow us to assess women’s thoughts on future use of the
method. It would also help us see whether they would rec-
ommend it to their friends.
Data were analysed using SPSS Statistics for Windows,
version 15.0 (SPSS, Chicago, IL, USA). The normality of data
was assessed using the Shapiro–Wilk test. Quantitative vari-
ables that were not normally distributed were represented
by median and range. The Mann–Whitney U test was used
to compare the groups. Frequencies and percentages were
calculated for quantitative variables. The v2 test and
Fisher’s exact test were used and a significance level of 5%
was chosen. Continuation rates were analysed using
Kaplan–Meier survival plots. The curves were compared
using the Mantel–Haenszel log-rank test. A significance
level of 5% was chosen. Satisfaction scores were calculated
using the Kruskal–Wallis test. Bonferroni correction was
used to calculate difference between groups. Cronbach’s
alpha was calculated to assess the internal consistency of
the scale. Bleeding patterns were compared for the COC
and CIC methods. The v2 test and Fisher’s exact test were
used to compare the groups.
Data were coded to ensure confidentiality. The study
was carried out in accordance with the Declaration of
Helsinki and was supervised by Dr Tahir Ghani, head of
Aziz Medical Centre. The study was approved by the
centre’s institutional review board (IRB 006-2016).
Results
The study comprised 171 women with a median age of 27
years (range 19–35 years) and a median parity of 2 (range
1–5). The median duration of intended use of the contra-
ceptive method was 2 years (range 1–3 years). Of the par-
ticipants, 109 (63.7%) were employed and 122 (71.3%) had
some formal education. Sixty women (35.1%) chose the
COC, 53 (31.0%) chose DMPA and 58 (33.9%) chose the
CIC. Table 1 shows the sociodemographic characteristics of
the study population.
DMPA was mostly chosen by older women (p ¼ .036)
and women who intended to use contraception for a lon-
ger period (3 vs 2 years; p ¼ .001). More women with no
formal education chose DMPA (p˂ .001). Table 2 shows a
comparison of participants’ characteristics with their choice
of contraception. Most of the educated women chose the
CIC (n ¼ 54, 93.1%) or COCs (n ¼ 56, 93.3%). CIC users had
a better continuation rate compared with COC or DMPA
users (p ¼ .034) (Figure 1).
Comparison of bleeding patterns on the final visit
showed that, compared with women using COCs, CIC users
were less likely to self-report light flow (86.2% vs 96.6%;
p ¼ .044) and more likely to report spotting (60.3% vs 3.3%;
p ˂ .001) (Table 3).
A higher proportion of women were satisfied or very
satisfied with the CIC (n ¼ 37, 63.8%). Women who chose
the CIC said they were likely or very likely to use it again
(n ¼ 37, 63.8%), while only 17 (28.3%) COC users and 13
(24.5%) DMPA users said they were likely or very likely to
use their method again. When asked about recommending
their chosen method, 15 (25.9%) CIC users said they would
Table 1. Sociodemographic characteristics of the study popula-
tion (N ¼ 171).
Characteristic Value
Age, years 27 (19–35)
Duration of contraceptive use, months 6 (1–12)
Duration of intended contraceptive use, years 2 (1–3)
Parity 2 (1–5)
Employment status
Unemployed 62 (36.3)
Employed 109 (63.7)
Educational status
No formal education 49 (28.7)
Some formal education 122 (71.3)
Chosen contraceptive method
CIC 58 (33.9)
COCs 60 (35.1)
DMPA 53 (31.0)
Data are presented as median (range) or n (%).
 THE EUROPEAN JOURNAL OF CONTRACEPTION & REPRODUCTIVE HEALTH CARE 3

Table 2. Comparison of participants’ characteristics with their choice of contraception.

Contraceptive method
p-value
Characteristic CIC (n ¼ 58) COCs (n ¼ 60) DMPA (n ¼ 53)
Age, years 26 (19–33) 26 (21–35) 29 (19–34) .036
Duration of contraceptive use, months 8 (1–12) 7 (1–12) 3 (3–12) .124
Duration of intended contraceptive use, years 1 (1–3) 2 (2–3) 2 (1–3) .001
Parity 2 (1–4) 2 (1–5) 2 (1–4) .069
Employment status .773
Unemployed 23 (39.7) 20 (33.3) 19 (35.8)
Employed 35 (60.3) 40 (66.7) 34 (64.2)
Educational status <.001
No formal education 4 (6.9) 4 (6.7) 41 (77.4)
Some formal education 54 (93.1) 56 (93.3) 12 (22.6)
Data are presented as median (range) or n (%).
The v2 statistic is significant at the 0.05 level.

1.0 CIC
COCs

0.8
DMPA
Cumulative continuation rate

0.6

0.4

0.2

0.0

0 2 4 6 8 10 12
Duration of contraceptive use (months)
Figure 1. Kaplan–Meier survival curves of women who continued method use during follow-up.

Table 3. Comparison of bleeding patterns of women using the CIC or COCs.

First visit Final visit
Self-reported bleeding characteristic CIC (n ¼ 58) COCs (n ¼ 60) p-value CIC (n ¼ 58) COCs (n ¼ 60) p-value
Menstrual cycle length, days
1–4 44 (75.9) 39 (65.0) .197 52 (89.7) 58 (96.7) .130
>4 14 (24.1) 21 (35.0) 6 (10.3) 2 (3.3)
Flow
Light 30 (51.7) 29 (48.3) .923 50 (86.2) 58 (96.7) .044
Moderate 24 (41.4) 27 (45.0) 8 (13.8) 2 (3.3)
Heavy 4 (6.9) 4 (6.7) 0 0
Spotting
No 48 (82.8) 50 (83.3) .934 23 (39.7) 58 (96.7) <.001
Yes 10 (17.2) 10 (16.7) 35 (60.3) 2 (3.3)
Data are presented as n (%). The DMPA group were excluded from the analysis because 43 of the 53 women became amenorrhoeic at 3 months.
The v2 statistic or Fisher’s exact test is significant at the 0.05 level.

not recommend it to a friend, and 43 (71.7%) COC users discontinuation in the CIC group was spotting (32.8%).
and 32 (60.4%) DMPA users would not recommend their Forgetting to take the pill was the most common reason
chosen method to a friend (Table 4). The internal consist- for discontinuation in the COC group (56.7%). Desire for
ency of the scale was calculated using Cronbach’s another method was the main reason in the DMPA group
alpha (0.917). (45.3%). Side effects were also significantly different
At the end of the study period more women continued (p ¼ .001) in the three groups. CIC users had bleeding prob-
with the CIC (n ¼ 17, 29.3%). The commonest reason for lems (29.3%), COC users reported nausea (36.7%) and
4 R. IZHAR ET AL.

Table 4. Satisfaction with the chosen contraceptive method.

Satisfaction CIC (n ¼ 58) COCs (n ¼ 60) DMPA (n ¼ 53) p-value
Are you satisfied with your method of contraception?
Very unsatisfied 0 (0.0) 1 (1.7) 0 .133
Unsatisfied 10 (17.2) 21 (35.0) 8 (15.1)
Neutral 11 (19.0) 23 (38.3) 30 (56.6)
Satisfied 32 (55.2) 13 (21.7) 10 (18.9)
Very satisfied 5 (8.6) 2 (3.3) 5 (9.4)
Would you like to use it again?
Very unlikely 2 (3.4) 14 (23.3) 0 .022
Unlikely 13 (22.4) 22 (36.7) 20 (37.7)
Neutral 6 (10.3) 7 (11.7) 20 (37.7)
Likely 13 (22.4) 8 (13.3) 8 (15.1)
Very likely 24 (41.4) 9 (15.0) 5 (9.4)
Would you recommend the method to a friend?
Definitely no 0 6 (10.0) 0 .046
No 15 (25.9) 37 (61.7) 32 (60.4)
Neutral 4 (6.9) 2 (3.3) 5 (9.4)
Yes 19 (32.8) 14 (23.3) 16 (30.2)
Definitely yes 20 (34.5) 1 (1.7) 0
Data are presented as n (%).
The Kruskal–Wallis test with Bonferroni correction was used to calculate the difference between groups.

Table 5. Compliance, reasons for discontinuation and side effects.

Variable CIC (n ¼ 58) COCs (n ¼ 60) DMPA (n ¼ 5) p-value
Compliant
Yes 17 (29.3) 6 (10.0) 8 (15.1) .019
No 41 (70.7) 54 (90.0) 45 (84.9)
Reason for discontinuation
Decided to use another method 9 (15.5) 12 (20.0) 24 (45.3) .001
Desire for pregnancy 13 (22.4) 8 (13.3) 8 (15.1)
Spotting 19 (32.8) 0 1 (1.9)
Forgetfulness 0 34 (56.7) 0
Weight gain 0 0 12 (22.6)
Not discontinued 17 (29.3) 6 (10.0) 8 (15.1)
Side effects .001
Bloating 1 (1.7) 1 (1.7) 18 (34.0)
Nausea 1 (1.7) 22 (36.7) 5 (9.4)
Acne 5 (8.6) 13 (21.7) 10 (18.9)
Bleeding problems 17 (29.3) 5 (8.3) 10 (18.9)
Mood changes 5 (8.6) 15 (25.0) 5 (9.4)
None 29 (50.0) 4 (6.7) 5 (9.4)
Data are presented as n (%).
The v2 statistic or Fisher’s exact test is significant at the 0.05 level.

DMPA users reported bloating (34%). However, 50% of CIC
users (vs 6.7% and 9.4% of COC and DMPA users, respect-
ively) reported no side effects (Table 5).
Discussion
Findings and interpretation
Our results show that women were more likely to continue
the CIC method. Satisfaction with the CIC was higher than
with DMPA or COCs. Almost a third of women, however,
experienced spotting while using the CIC which led them
to discontinue use.
Women require rapid access to their contraceptive of
choice [11]. In our study, 31% of women chose DMPA and
35% chose the COC, which is in agreement with studies
worldwide: women use COCs more than any other method
[12]. Contraceptive use depends on education and the
intended duration of use of the method. In our study, older
women and those who were not planning a pregnancy in
the near future chose DMPA. These results are in agree-
ment with those of previous studies [13]. In our analysis,
educated women mostly chose the CIC or COCs.
Few women were compliant to the end of the study,
but the continuation rate was superior in CIC users.
Nevertheless, only 29.3% of participants continued to use
the CIC, which is much lower than the rate (34.5%)
obtained in an Iranian study [14] but higher than that
reported from Mexico (26%) [15]. A continuation rate of
81% was reported from China [16]. A discussion on con-
tinuation rate is incomplete without mentioning the rea-
sons for discontinuation. The women in our study
discontinued the CIC method because of spotting (32.8%).
Pakistan is a Muslim country where women are particularly
concerned about bleeding patterns, because bleeding
affects their religious obligations. Irregular bleeding (65.6%)
was also the most common reason for discontinuation in
Iran [17], also a Muslim country. Forgetfulness (56.7%) was
the main reason for discontinuation in the COC group. The
need for daily pill intake is a major hurdle in uptake of this
method. Around half of users report problems with adher-
ence [18]. Women are at a risk of unintended pregnancy
with non-adherence. Side effects also contribute to discon-
tinuation. Women faced different side effects with different
preparations. CIC users reported bleeding problems
(29.3%), COC users nausea (36.7%), and DMPA users bloat-
ing (34.0%). These reported side effects are similar to those
previously reported [19].
Every method has some side effects, but some are
acceptable to women while others are not. Acceptability
impacts satisfaction and continuation of a method. We
 THE EUROPEAN JOURNAL OF CONTRACEPTION & REPRODUCTIVE HEALTH CARE
assessed satisfaction on a scale designed to include each
participant’s preference. Many factors mould preferences,
and most satisfaction scales do not gauge what women
want [20]. Almost 64% of women were satisfied or very sat-
isfied with the CIC, but only 25.0% of COC users and 28.3%
of DMPA users were satisfied or very satisfied with their
chosen method. Higher satisfaction led to better method
continuation. But only 17 (29.3%) in the CIC group, six
(10.0%) in the COC group and eight (15.1%) in the DMPA
group were compliant to the end of study. This result con-
firms that CIC is a promising contraceptive option.
Femiject is not available everywhere in the country, but
women can help become advocates for its use. Supply of
contraceptives is according to demand. When more con-
sumers request a method, availability improves [21].
Femiject users were likely or very likely to use it again
(63.8%), compared with only 28.3% of COC users.
Contraceptive use is also affected by recommendation.
Women’s preferences are complex. A huge difference exists
between the method they use and the method they want
to use [22]. Some women claim they do not know enough
to choose a method. When choosing a method, they are
more likely to trust their friend than trust a health care pro-
vider [19].
Our study shows that CIC is a good option for women
requesting contraception and, considering the high drop-
out rate in women using DMPA, it provides another inject-
able option. The once monthly administration is a plus
point compared with COCs. Fewer bleeding disturbances
make CIC a superior choice compared with DMPA.
Comparison with other LARC methods still needs to
be done.
Strengths and limitations
The study had a prospective design and patients were fol-
lowed up for a year. We designed a scale to assess satisfac-
tion that allowed women to project their thoughts. The
satisfaction scale was ordinal so that women could answer
the questions used to assess satisfaction at a personal level.
Women are more likely to continue and advocate a
method if they find it easy to use. The major limitation of
the study was that we did not collect data on efficacy of
the method, nor did we use a validated birth control satis-
faction assessment tool [23]. Participants were recruited
from a medical centre that serves all communities. The
sample is thus representative of the whole population.
However, as the discontinuation rates of all methods were
far from ideal, generalisation of the results may be of con-
cern. Finally, owing to the small sample size, the
Kaplan–Meier survival curves crossed. A larger sample size
would help improve statistical analysis in future studies.
Implications for clinicians and policy-makers/health
care providers
An awareness programme on the availability of Femiject is
needed. Women should be given a 3 month supply. Our
study should help clinicians give users an estimate of the
method’s performance.
5
Future research
Future large multicentre trials are needed to assess the effi-
cacy and uptake of Femiject.
Conclusion
The continuation rate, level of satisfaction and bleeding
profile achieved with CICs is promising and uptake should
be encouraged. Our study shows that CIC is a good option
for women requesting contraception.
Disclosure statement
No potential conflict of interest was reported by the author(s).
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