1. Combined Oral Contraceptive Pills (COCs)
Session I: Characteristics of COCs

2. Combined Oral Contraceptives Objectives
Participants will be able to:
Describe the characteristics of COCs in a manner that clients can understand
Demonstrate how to screen clients for eligibility for COC use
Describe when to initiate COCs
Explain how to use COCs, what to do when pills are missed, and when to return
Address common concerns, misconceptions, and myths
Explain how to manage side effects
Identify conditions that require switching to another method
Identify clients in need of referral for COC-related complications
The learning objectives for this module are based on input from various stakeholders <insert who provided input: participants, supervisors, health officials>.
The objectives of this module are as follows: By the end of this training session, participants will be able to: <click the mouse to advance through the objectives, reading each objective aloud >.
• Explain that the learning objectives will be assessed through knowledge assessments, role plays and the use of skills checklists.
• Solicit input about whether the planned objectives match participant’s expectations of the training.
• Distribute the pre-test.

3. COCs Key Points for Providers and Clients
Take a pill every day.
Contains both estrogen and progestogen hormones.
Works mainly by stopping ovulation.
Effectiveness depends on the user. Can be very effective.
“Would you remember to take a pill each day?”
No need to do anything at time of sexual intercourse.
Very effective if taken every day. But if woman forgets pills, she may become pregnant.
Easy to stop: A woman who stops pills can soon become pregnant.
Very safe.
Pills are not harmful for most women’s health and studies show very low risk for cancer due to pills for almost all women. The pill can even protect against some types of cancer.
Serious complications are rare. They include heart attack, stroke, blood clots in deep veins of the legs or lungs.
Some women have side-effects at first–not harmful and often go away after first 3 months.
Side-effects often go away after first 3 months.
No protection against STIs or HIV/AIDS.
For STI/HIV/AIDS protection, also use condoms.
Adapted from WHO’s Decision-making tool for family planning clients and providers.
Explain: The key points to remember about COCs are that: one pill must be taken every day; effectiveness depends on the user; COCs are very safe, they help reduce menstrual bleeding and cramps, some women have side effects at first (these are not harmful); and COCs don’t provide protection against STIs or HIV/AIDS.

4. What Are COCs? Traits and Types
Content
Combination of two hormones: estrogen and progestin
Phasic
Monophasic, biphasic, triphasic
Dose
Low-dose: µg of estrogen (common), 20 µg or less (rare in most places)
Pills per pack
21: all active pills (7-day break between packs)
28: 21 active + 7 inactive pills (no break between packs)
Ask the participants: What are some traits that differ among combined oral contraceptive pills? <allow participants to answer; click the mouse to reveal the following traits>
• COCs can differ in hormone content, dosage, and number of pills per pack. All combined oral contraceptive pills contain ethinyl estradiol, which is a synthetic estrogen, and one of the various types of progestin. The most common type of combined pill is monophasic, in which the hormone content is constant in all 21 active pills.
• COCs are also available as biphasic and triphasic pills, in which the ratio of estrogen to progestin varies among the active pills two or three times during the cycle. There are no clinically significant differences in effectiveness or safety between multiphasic and monophasic pills.
• Both the type and the amount of hormone contained in each formulation of pill are related to its potential for side effects. The low-dose pills used today generally contain 30 to 35 micrograms (µg) of ethinyl estradiol and have a much lower potential for side effects than older high-dose pills containing 50 µg of estrogen (commonly used until the late 1970s and now used primarily for emergency contraception). Some types of low-dose pills contain as little as 20 µg of estrogen, but they are rare in most places.
• COCs are packaged with either 21 or 28 pills per pack. The 21-pill pack contains only active pills and requires women to take a seven-day break between packs. The 28-pill pack contains 21 active pills and seven inactive or hormone-free pills. These inactive pills are included to minimize the risk of women forgetting to start a new pack of pills on time after a seven-day break. The seven-day period, during which no active pills are taken, is called the “hormone-free interval.” Most women have their menstrual bleeding during this hormone-free interval.
• Ask the participants: Which brands of pills are available in the facility where they work (or in their country, pharmacy, or program). Allow participants to answer and add to the participants’ responses as needed. How are COCs different from POPs? <allow participants to answer; probe for the following> POPs contain only progestin, all the pills in POP packs are active and each pill contains the same amount of hormone, and there are no hormone-free intervals or breaks between packs.

5. Effectiveness of COCs
In this progression of effectiveness, where would you place combined oral contraceptives (COCs)?
Less effective
More effective
Implants
Male Sterilization
Female Sterilization
Intrauterine Devices
Progestin-Only Injectables
Male Condoms
Standard Days Method
Female Condoms
Spermicides
Ask participants: Where would you put combined oral contraceptives on this list?
After participants respond, click the mouse to reveal the answer
The purpose of this activity is to emphasize the effectiveness of combined oral contraceptives.
• Inform: The list on these slides categorizes contraceptive methods from most effective to least effective as commonly used. In this list, spermicides are the least effective method and the most effective methods are contraceptive implants, sterilization, and IUDs.
COCs

6. Relative Effectiveness of FP Methods
# of unintended pregnancies among
1,000 women in 1st year of typical use
No method
850
Withdrawal
220
Female condom
210
Male condom
180
Pill 90
Injectable 60
IUD (CU-T 380A / LNG-IUS)
8 / 2
Female sterilization 5
Vasectomy
1.5
Implant
0.5
Source: Trussell J., Contraceptive Failure in the United States, Contraception 83 (2011) , Elsevier Inc.
Explain that there is another way to look at effectiveness. In this slide we look at how effective FP methods are as they are commonly used. The slide shows the number of women who would get pregnant if 1,000 women used a method for one year. So, if 1,000 fertile women who were having sex, but not using any protection from pregnancy, 850 of them would become pregnant. But, if the same 1,000 women were using an COCs, 90 would become pregnant. Ask participants- what if these same women were using an IUD? How many would become pregnant. As part of good counseling, it is important to inform clients about how effective each method is.
See Session Plan for roleplay.

7. COCs: Mechanism of Action
Suppresses
hormones
responsible for
ovulation
Illustration credit: Salim Khalaf/FHI
The purpose of this activity is to keep participants focused on how they translate technical information into concepts that their clients can understand.
For women who are interested in this method, how will you explain how COCs work?
Brainstorming instruction:
Ask participants to brainstorm ideas about how to explain how COCs work to prevent pregnancy, using simple language the client will understand. For example, “Your body stops producing eggs for as long as you take the pill so you cannot get pregnant.” Encourage participants to use pages or illustrations from counseling tools to help with their explanations.
Thickens
cervical mucus to block sperm
COCs have no effect on an existing pregnancy.

8. COCs: Characteristics
Safe and more than 99% effective if used correctly
Can be stopped at any time
No delay in return to fertility
Are controlled by the woman
Do not interfere with sex
Have health benefits
Less effective when not used correctly (91%)
Require taking a pill every day
Do not provide protection from STIs/HIV
Have side effects
Have some health risks (rare)
Ask participants to work in teams to create a list of the positive characteristics (advantages) of COCs and the characteristics of COCs that clients may perceive as negative (limitations) on separate sheets of flip chart paper. Encourage participants to think about their own experiences with clients who have used COCs.
Tell the teams they will have exactly two minutes to create their lists. Signal the teams at the start and stop times, give a 30-second warning notice before the stop time, and ensure that teams put down their markers at the stop time.
After the stop signal, ask teams present their lists to the larger group. After all the groups have presented, ask participants to examine the lists and compare whether all the groups agreed about whether particular characteristics were positive or negative. Ask the participants to consider whether there may be clients who would perceive certain “beneficial” characteristics to be undesirable, and vice versa.
Remind participants that women with similar characteristics in similar situations may have different reasons for making method choices. When counseling women, it is important to help clients consider how these method characteristics fit their lifestyles and reproductive health goals and desires.
Award a token prize to the team with the most thorough lists.
As you review the next few slides in the presentation, refer to the lists that the participants developed.
iscussion (10 min.)
The purpose of this activity is to give participants an opportunity to think about how a clients’ perception of a particular characteristic of COCs may be affected by the client’s situation.
Ask participants to share the reasons that women in their community may have for liking COCs. For example: COCs are easy to start and stop; they are available from a community-based health worker (CHW); they were recommended by COC users; allow for more predictable menstrual cycles; or that there is nothing to remember at the time of intercourse.
Ask participants to consider why women in different situations may prefer or avoid use of COCs because of a particular characteristic. For example, a young woman or a woman with many children who is very busy may have trouble remembering to take the pill on time; a young woman may desire a method that is easy to discontinue when she wants to get pregnant; a woman with HIV who wants to avoid pregnancy may prefer a different method in which effectiveness is not user-dependent.
Remind participants that women with similar characteristics in similar situations may have very different reasons for making method choices. When counseling women it is important to help clients consider how these method characteristics fit with their lifestyles and reproductive health goals and desires.
Source: Hatcher, 2007; WHO, 2010; CCP and WHO, 2011; Trussell , 2011.

9. COCs: Menstrual-Related Health Benefits
5/25/2012
COCs: Menstrual-Related Health Benefits
Decreased amount of flow and fewer days of bleeding; no bleeding (less common)
Regular, predictable menstrual cycles
Reduced pain and cramps during menses
Reduced pain at time of ovulation
Discussion (10 min.)
Ask participants to think back to the discussion of why women like COCs. One reason that women tend to like COCs is their effect on the menstrual cycle.
Ask participants: What are some of those effects? <accept responses from several participants>
Let us compare your responses with the information on the slide. <click the mouse to reveal each bullet on the slide>
Studies show that COCs decrease the amount of menstrual flow and reduce the number of days of menstrual bleeding. Some women may develop amenorrhea, but this is not very common.
About 90 percent of women taking COCs experience regular monthly cycles: their menses predictably come during the hormone-free interval. COCs reduce the pain and cramps that commonly occur during menses or in mid-cycle at the time of ovulation. They can also relieve the symptoms of dysmenorrheal (painful menses) and are often prescribed for treatment of this condition.
Source: Davis, 2005.

10. COCs: Other Health Benefits
Protection from:
Risks of pregnancy
Ovarian cancer
Endometrial cancer
Symptomatic PID
Reduced risk of:
Ovarian cysts
Iron-deficiency anemia
Decreased symptoms of endometriosis (pelvic pain, irregular bleeding)
Decreased symptoms of polycystic ovarian syndrome (irregular bleeding, acne, excess hair on face or body)
Other Health Benefits
Discussion (10 min.)
Ask participants: What are some of the health benefits of COCs that you have heard about? <accept responses from several participants>
Use slides to present the following:
COCs are very effective at preventing pregnancy. As a result, they dramatically lower a woman’s risk of pregnancy-related complications, including having an ectopic pregnancy, which is a potentially life-threatening condition.
There is lingering concern that COCs may cause cancer. In fact, COCs protect women against ovarian and endometrial cancer. Many studies have demonstrated that COC users have less than half the risk of developing these cancers compared to non-users.
It has also been observed that among women who take COCs, there are fewer symptomatic cases of pelvic inflammatory disease (PID). It is not clear if COCs prevent PID or make PID symptoms less severe.
COCs offer other health benefits as well. Because COCs inhibit ovulation, they have been shown to reduce the risk of functional ovarian cysts.* It was found that the amount of bleeding in women who use COCs is reduced by 50 percent on average, which helps to reduce risk of iron-deficiency anemia. Additionally, the inactive pills in some brands contain iron, which may further reduce the risk of anemia.
COCs inhibit the growth of endometrial tissue, so they are very effective in reducing symptoms of endometriosis, a condition in which endometrial tissue is found outside the uterus, leading to pelvic pain.
COCs are also known to decrease symptoms of polycystic ovarian syndrome, such as irregular bleeding, acne, and excess hair on face and body.
Source: Petitti and Porterfield, 1992; CASH Study, 1987; CCP and WHO, 2011; Belsey, 1988; Davis, 2007.

11. No Overall Increase in Breast Cancer Risk for COC Users
Analysis of a large number of studies:
No overall increase in breast cancer risk among women who had ever used COCs
Current use and use within past 10 years: very slight increase in risk
May be due to early diagnosis or accelerated growth of pre-existing tumors
More recent study:
No increase in breast cancer risk regardless of age, estrogen dose, ethnicity, or family history of breast cancer
Use slide to present the following:
The Collaborative Group on Hormonal Factors in Breast Cancer reanalyzed data from 54 independent studies conducted in 25 countries.
The analysis of these older studies showed:
No overall increase in the risk of developing breast cancer among women who have ever used COCs.
A very slight increase in the risk of breast cancer among current COC users and women who have used COCs within the past 10 years. Researchers speculate that these findings may be due to an accelerated growth of already existing tumors or to earlier detection of breast cancer in COC users because they come into contact with health care providers on a regular basis. In other words, while the overall number of breast cancer cases seems to be the same for COC users and non-users, the cases are distributed differently over time. Among COC users, more cases are diagnosed earlier in life, and among non-users the number of cases is the same, but they are diagnosed later in life.
A more recent study found no increased risk of breast cancer in current or former COC users between the ages of 35 and 64. This was true regardless of age at COC initiation, estrogen dose, length of COC use, or the presence of other risk factors such as family history of breast cancer or ethnicity. While consensus is still being developed about how this new data contribute to the understanding of the relationship between COC use and breast cancer, it is clear that the lifetime risk of breast cancer is similar for both COC users and non-users.
Source: Collaborative Group on Hormonal Factors in Breast Cancer, 1996; Marchbanks, 2002.

12. COCs and Cervical Cancer
Cervical cancer is caused by certain types of human papillomavirus (HPV)
Some increase in risk among women with HPV and others who use COCs more than 5 years
Risk of cervical cancer goes back to baseline after 10 years of non-use
Cervical cancer rates in women of reproductive age are low. Risk of cervical cancer at this age group is low compared to mortality and morbidities associated with pregnancy.
Cervical cancer is caused by certain types of human papillomavirus, or HPV, a sexually transmitted virus.
Studies have found some increase in the risk of developing cervical cancer among women with HPV who use COCs for more than five years.
Studies also have shown that the risk declined after COC use ends, and by 10 years after discontinuation had returned to the level of women who had never used COCs. A similar pattern of risk was seen both for invasive and in-situ cancer, and in women who tested positive for high-risk human papillomavirus.
However because cervical cancer rates in women of reproductive age are generally low, the absolute number of cervical cancer cases attributable to COC use is thought to be very small. One large study estimates that in women who were using COCs for 10 years—from age 20 to 30 —by the time they are 50 the total number of cervical cancer cases increases by no more than 0.1 percent (one additional case per 1,000 women).
If cervical screening is available, it is recommended that COC users follow the same screening schedule as all other women.
COC users should follow the same cervical cancer screening schedule as other women.
Source: Smith, 2003; Appleby, 2007; CCP and WHO, 2011.

13. Risk of Blood Clots is Limited
COCs may slightly increase risk of blood clots:
Stroke
Heart attack
Risk is concentrated among women who have additional risk factors, such as:
Hypertension
Diabetes
Smoking
Deep vein thrombosis
Pulmonary embolism
The estrogen component of the combined pill may slightly increase the risk of blood clots in veins or arteries, including stroke, myocardial infarction (heart attack), deep vein thrombosis (DVT), and pulmonary embolism (PE).
However, because the estrogen component of the pill has been progressively reduced over the past few decades, the risk of blood clots with current low-dose COCs—containing 35 µg or less of estrogen—is much smaller than with older, high-dose COCs. COCs containing third generation progestins, such as gestodene and desogestrel, have also been associated with somewhat higher risk of blood clots, but this risk is still significantly smaller than the risk of blood clots during pregnancy.
It is important to put the increased risk for blood clots in perspective. Stroke, heart attack, deep vein thrombosis, and pulmonary embolism are extremely rare in women of reproductive age—especially younger women. Therefore, a small increase in risk due to COC use will result in a very small number of additional cases.
The risk of blood clots is higher in reproductive-age women who have other risk factors such as hypertension, diabetes, or smoking. The number of heart attacks is higher in older COC users who smoke or have high blood pressure compared to healthy COC users. This is why it is important to screen for existing risk factors prior to starting COCs.
In the rare event that a blood clot develops, COCs must be discontinued immediately. Later in this presentation, we will discuss specific symptoms that may accompany blood clots.
See Session Plan for Group Activity
Stop COCs immediately if a blood clot develops.
Source: World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception ,1995; Jick, 2006; WHO, 1998; Farley, 1998.

14. Possible Side-Effects
If a woman chooses this method, she may have some side- effects. They are not usually signs of illness.
But many women do not have any side-effects.
Side-effects often go away after a few months and are not harmful.
Most common:
Mood changes or headaches
Tender breasts
Changes in bleeding patterns (lighter, irregular, infrequent or no monthly bleeding)
Slight weight gain or loss
Nausea (upset stomach)
Dizziness
Adapted from WHO’s Decision-making tool for family planning clients and providers.
Remind participants that as with many contraceptive methods, there are some side effects associated with COCs that are not harmful but may be unpleasant.
Women’s preferences for certain methods are often related to side effects. Ask the participants: What side effects of COCs, have you heard about?
As we have acknowledged, some women who take COCs experience certain side effects. These side effects may include nausea, dizziness, headaches, breast tenderness, and mood swings. COCs may also cause bleeding changes.
Most women experience a reduction in the amount of menstrual bleeding. The majority of women have regular menstrual bleeding while taking COCs; however, some women may experience amenorrhea while others have breakthrough bleeding, or irregular bleeding between periods. This bleeding ranges from spotting to light bleeding episodes.
Because some cultures or religions restrict sexual and religious activities during menstruation, breakthrough bleeding may interfere with a woman’s daily life. Breakthrough bleeding is generally not harmful to a woman’s health.
Studies show COCs have no negative effect on hemoglobin or iron levels and may even help prevent iron-deficiency anemia.
It is important to remember that many COC users do not experience any side effects. Those who do experience side effects may experience one or two of these side effects, but not all of them.
Typically, side effects diminish within a few months after a woman begins COC use.
Because these side effects may have an important impact on users’ experience with COCs, they should be addressed during counseling and follow-up visits.