1. Session I: Characteristics of Progestin-Only Injectables
Progestin-Only Injectable Contraceptives
Session I: Characteristics of Progestin-Only Injectables
Photo credit: FHI (packaging from socially marketed DMPA in Kenya and Uganda)

2. Objectives At the end of this session, participants will be able to:
Describe the characteristics of progestin-only injectables in a manner clients can understand:
What progestin-only injectables are and how they work (mechanism and onset of action)
Effectiveness
Side effects
Non-contraceptive health benefits
Possible health risks (complications)
Other characteristics (STI/HIV protection, ease of use, return to fertility, when to initiate and discontinue)
By the end of this training session, participants will be able to: <click the mouse to advance through the objectives, reading each objective aloud>.
Progestin-only injectable contraceptives are safe and highly effective, and many women find that they are convenient to use.
Injectables can be provided in different settings by a wide range of providers. Providers find that injectables are easy to provide, and many women find that they are easy to use.
The session is designed to address the objectives for this method listed in the Facilitator’s Guide and on the slide set.
This presentation provides an overview of the characteristics of this method. It also provides training on how to counsel, screen, and provide follow-up to clients who are interested in using progestin-only injectables as a way to regulate their fertility.
During this training you will learn and demonstrate these skills during role plays and other activities. You will also be encouraged to think about what it will be like to perform these tasks on-the-job.
Review objectives with participants.
Solicit input about whether the planned objectives match participant’s expectations of the training.

3. Objectives Demonstrate the ability to:
Screen clients for medical eligibility for injectables
Explain to clients the insertion, removal, and follow-up procedures
Explain when to return to the clinic
Address common concerns, misconceptions, and myths
Conduct follow-up for injectable clients in a way that enhances continuing safety, satisfaction, and acceptance
Describe when to start use of injectables.
Explain how to manage side effects.
Identify conditions that require switching to another method.
Identify clients in need of referral for injectable-related complications.
Demonstrate the preparation of supplies, equipment, and the client and the technique of administration (using a fruit or vegetable).
By the end of this training session, participants will be able to: <click the mouse to advance through the objectives, reading each objective aloud>.

4. Key Points for Providers and Clients
An injection every 2 or 3 months, depending on type
• Return for injections regularly. Coming back every 3 months (13 weeks) for DMPA or every 2 months for NET-EN is important for greatest effectiveness.
Very effective and safe
Very effective, provided client returns for injection at right time.
Do not cause any serious health problems, cancer, or infertility, nor do they produce any significant change in blood pressure.
Can be used while breastfeeding
Safe for breastfeeding women, they do not affect the quality of the breast milk. Starting as soon as 6 weeks after birth
Possible side effects
Weight gain, headaches, dizziness, and changes in monthly bleeding
Adapted from WHO’s Decision-making tool for family planning clients and providers.
Discuss the key points that are important for both clients and providers.
• Return for injections regularly. Coming back every 3 months (13 weeks) for DMPA or every 2 months for NET-EN is important for greatest effectiveness.
• Projestin- only injectables are very effective and safe, provided client returns for injection at right time. Do not cause any serious health problems, cancer, or infertility, nor do they produce any significant change in blood pressure.
• For breastfeeding women, they do not affect the quality of the breast milk.
• Possible side effects include weight gain, headaches, dizziness and changes in monthly bleeding.

5. Key Points for Providers and Clients
Often takes longer to get pregnant after stopping
After stopping progestin-only injectables, there is a delay of several months before most women can get pregnant, and for some women it may be even longer.
They do not make women permanently infertile.
Changes in monthly bleeding
The most commonly reported side effects of progestin-only injectables are menstrual changes.
In the first three to six months, women using progestin-only injectables commonly experience irregular bleeding or spotting and prolonged bleeding. After one year, women commonly experience infrequent bleeding, irregular bleeding and amenorrhea.
No protection against STIs or HIV/AIDS
Provide no protection from STIs/HIV.
For STI/HIV/AIDS protection, also use condoms.
Adapted from WHO’s Decision-making tool for family planning clients and providers.
• Return of fertility is often delayed. It takes several months longer on average to become pregnant after stopping progestin-only injectables than after other methods.
Changes in monthly bleeding: The most commonly reported side effects of progestin-only injectables are menstrual changes. In the first three to six months, women using progestin-only injectables commonly experience irregular bleeding or spotting and prolonged bleeding. After one year, women commonly experience infrequent bleeding, irregular bleeding and amenorrhea
• Injection can be as much as 4 weeks late for DMPA or 2 weeks late for NET-EN. Client should come back even if later.
• Provides no protection from STIs/HIV. For STI/HIV/AIDS protection, also use condoms.
Note to facilitator: If participants also provide combined injectables (contain both estrogen and progestin and given monthly), clarify that although both are given by injection, they have many important differences. This presentation addresses only progestin-only injectables.

6. Types of Progestin-Only Injectables
DMPA (depot medroxyprogesterone acetate)
Given either into the muscle (DMPA-IM, known as Depo, or Depo-Provera) or under the skin (DMPA-SC, known as Sayana Press or depo-subQ provera 104)
Injection every 3 months (13 weeks)
NET-EN (norethisterone enanthate)
Injection every 2 months (8 weeks)
Have similar effectiveness, safety, characteristics and eligibility criteria
Photo credits: News-Leader, ©2005 Springfield, MO; Museum of Contraception and Abortion, ©2007 Vienna
There are two types of progestin-only injectables: DMPA (depot medroxyprogesterone acetate) and NET-EN (has two chemical formulations: norethindrone enanthate and norethisterone enanthate). Each contain a progestin like the natural hormone progesterone in a woman’s body.
DMPA and NET-EN are given as intramuscular injections in one of three sites: the muscles of the upper arm, the muscle of the hip, or in the buttock.
A woman can decide where she prefers to receive the injection. Ask participants to consider how they will talk with their clients about where they prefer to have their injection. Remind participants that some clients will be anxious about receiving an injection, so being able to discuss how the procedure will be performed is an important part of making their clients feel comfortable.
Note: See additional text in Session Guide
Reminder: progestin-only injectables are different from combined injectable contraceptives. Combined injectables contain both a progestin and an estrogen. They are known as CICs or monthly injectables, because injectables are given once a month. This presentation addresses only progestin-only injectables.
Source: CCP and WHO, 2010; Kingsley, 2010.

7. Effectiveness of Injectables
In this progression of effectiveness, where would you place progestin-only injectables?
Implants
Male Sterilization
Female Sterilization
Intrauterine Devices
Combined Oral Contraceptives
Male Condoms
Standard Days Method
Female Condoms
Spermicides
More effective
Ask participants: Where would you put progestin-only injectables, or DMPA, on this list? After participants respond, click the mouse to reveal the answer.
The purpose of this discussion is to emphasize the effectiveness of progestin-only injectables.
The list on this slide 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 sterilization and implants.
Ask participants: Where would you put progestin-only injectables on this list? <after participants respond, click the mouse to reveal the answer>
Conduct Counseling Role Plays conveying information about method effectivness.
Conclude by emphasizing that progestin-only injectables are at the top of the second tier of methods, as they are very effective methods of contraception. Only the intrauterine device (IUD), male and female sterilization, and implants are more effective than progestin-only injectables.
Emphasize that effectiveness depends on getting injections regularly. The risk of pregnancy is greatest when a woman misses an injection.
Injectables
Less effective

8. Relative Effectiveness of Family Planning 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 30
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 injectable, 30 would become pregnant.
As a part of good counseling, it is important to inform clients about how effective each method is.
Ask participants:
What if these same women were using the pill? How many would become pregnant?

9. Progestin-Only Injectables: Mechanism of Action
Thicken cervical mucus to block sperm
Suppress hormones
responsible for
ovulation
Note: Do not disrupt existing pregnancy
Explain that progestin-only injectables prevent pregnancy in two ways:
The primary mechanism of action is to suppress ovulation. Progestin causes the hypothalamus and the pituitary gland to reduce production of the hormones that are necessary for ovulation. Without ovulation, there is no egg to be fertilized.
Progestin also thickens the cervical mucus. The thickened mucus makes it more difficult for sperm to enter the uterine cavity. In the unlikely event that a woman does ovulate, this mucus barrier greatly reduces the chance that the egg will be fertilized.
Other contraceptive methods that work this way are implants and combined oral contraceptives (COCs).
Progestin-only injectables do not disrupt an existing pregnancy and do not harm a fetus if a woman is accidentally given this method when she is already pregnant. However, if it is determined that a woman who is using injectables is, indeed, pregnant, she should stop receiving injections.
Note to facilitator: In many places it is a common myth that injectables will abort an existing pregnancy or harm a fetus, so it is important to counter this belief and emphasize the fact that progestin-only injectables do not disrupt an existing pregnancy or harm a fetus if a woman is already pregnant when she has receives an injection. More information about misconceptions and rumors about injectables will be discussed further in Session III.
Source: Kingsley F and Salem R,

10. Characteristics of Progestin-Only Injectables
Safe and very effective
Easy to use; requires no daily routine
Long-lasting and reversible
Can be discontinued without provider’s help
Can be provided outside of clinics
Can be used by breastfeeding women
Use can be private
Does not interfere with sex
Can be used by breastfeeding women
Provide non-contraceptive health benefits
Have side effects
Cause delay in return to fertility
Effectiveness depends on user getting injections regularly
Provide no protection from STIs/HIV
Instructions for facilitator:
Ask participants to brainstorm first a list of positive characteristics (advantages) and then negative characteristics (limitations) of progestin-only injectables. Write these suggested characteristics on a flip chart. Then show the slides of characteristics of progestin-only injectables and compare them to the list generated through brainstorming.
If you use the terms advantages and limitations, mention that the same characteristic of a FP method may be an advantage for one person and a limitation to another.
Discuss and correct any misconceptions and counter any myths that may arise about progestin-only injectables.
Remind participants that people with similar characteristics in similar situations may have very different reasons for making choices about contraceptive methods. When counseling clients it is important to help them consider how these method characteristics fit with their lifestyles and reproductive health goals and desires.
Source: CCP and WHO, 2011

11. Progestin-Only Injectables: Health Benefits
Help protect against:
Risks of pregnancy
Endometrial cancer
Uterine fibroids
May help protect against symptomatic pelvic inflammatory disease (PID) and iron-deficiency anemia
Reduce sickle cell crises in women with sickle cell anemia
Reduce symptoms of endometriosis (pelvic pain, irregular bleeding)
In addition to preventing pregnancy, progestin-only injectables provide a number of health benefits to users including:
They help protect against endometrial cancer and uterine fibroids.
They may help protect against symptomatic pelvic inflammatory disease (PID) and iron-deficiency anemia.
They reduce sickle cell crises in women with sickle cell anemia
They also reduce the symptoms of endometriosis, including pelvic pain, and irregular bleeding.
NET-EN may offer many of the same health benefits as DMPA, but this list of benefits includes only those for which there is available research evidence.
Source: CCP and WHO, 2011; Manchikanti, 2007.

12. Injectables and Risk of Breast Cancer
No effect on overall risk of breast cancer
Older studies found a somewhat increased risk during first 5 years of use
May be due to detection bias or accelerated growth of pre-existing tumors
Recent large study found no increased risk in current or past DMPA users regardless of age and duration of use
Little research has been done on NET-EN
Progestin-only injectables have no effect on a client’s overall risk of breast cancer. Older studies had found a somewhat increased risk of breast cancer among current users. But this finding was probably due to detection bias or accelerated growth of pre-existing tumors.
A recent large study found no increased cancer risk in current or past DMPA users regardless of age and duration of use.
No studies were done for NET-EN.
Source: Strom et al, 2004

13. Effect of DMPA on Bone Density
DMPA users have lower bone density than non-users
Women initiating DMPA use as adults regain most lost bone
Long-term effect in adolescents unknown
Concerns about reaching peak bone mass
Long-term studies are needed
Generally acceptable to use
Most studies have found that DMPA users have lower bone density than non-users, especially women age 21 or younger. A woman’s bones normally reach their maximum density during adolescence, but the use of DMPA during adolescence may affect peak bone mass.
Women who start using DMPA as adults appear to regain most of the lost bone after they stop using DMPA.
However, it is not yet known whether bone loss in adolescents and young women is completely reversible. One study found that adolescent NET-EN users recovered bone mass density after discontinuing.4 However, long-term studies are needed to determine whether DMPA use increases the risk of fracture, especially in women who begin using DMPA during adolescence.5 Currently, DMPA use is considered to be generally acceptable for adolescent clients, because preventing risks associated with unwanted pregnancy at a young age outweigh the theoretical risk of fracture later in life.
Source: Cromer, 1996; Cundy, 1994; WHO, 2010.

14. Infant Exposure to DMPA/NET-EN During Breastfeeding
DMPA and NET-EN have no effect on:
Onset or duration of lactation
Quantity or quality of breast milk
Health and development of infant
Photo credit: ©1991 Lauren Goodsmith, Courtesy of Photoshare
DMPA and NET-EN have been used extensively by women who are breastfeeding. Because DMPA and NET-EN are partially excreted through breastmilk, a breastfeeding infant swallows a small amount of hormone, which enters the child’s circulatory system. Studies have shown that DMPA has no adverse effects on the onset or duration of lactation; the quantity or quality of breastmilk; or the health and development of nursing infants.
Note to Facilitator: Slides 2 and 4 in session II represent the international consensus on the initiation of implants and breastfeeding as reflected in the WHO MEC. For further information on the initiation of implants and breastfeeding, see slide 10 in session II.  This consideration will be more fully discussed at that time.
Initiation before 6 weeks postpartum is generally not recommended. (WHO/MEC)
Source: Koetsawang, 1987; WHO Task Force for Epidemiological Research on Reproductive Health, 1994a and 1994b; Kapp 2010; WHO, 2008; WHO, 2010; WHO, 2004, updated 2008.

15. Injectables: Return to Fertility
Return to fertility depends on how fast a woman fully metabolizes the injectable
On average, women become pregnant 9–10 months after their last injection of DMPA
Length of time injectable was used makes no difference
Return to fertility for injectables users depends on how long it takes a woman to fully metabolize the DMPA or NET-EN from her last injection. Because women differ in how they metabolize DMPA and NET-EN, there is considerable variability in how long it takes to become pregnant after discontinuation.
In the case of DMPA, on average, women can become pregnant nine to 10 months after their last DMPA injection. Some women may become pregnant as soon as four months after the last injection, but a small percentage may take as long as 18 months. The average time it takes to become pregnant after discontinuing injectables is about four months longer for DMPA users and about one month longer for NET-EN users than for women who use other modern methods. The difference in fertility between former DMPA users and former users of other contraceptives disappears approximately 16 months after discontinuation.
The length of time a woman has used DMPA or NET-EN makes no difference in return to fertility.
Because of the delay in return to fertility, women should be counseled to consider discontinuing DMPA or NET-EN several months before the time they want to conceive.
Sources: Pardthaisong, 1984; Schwallie, 1974.

16. Progestin-Only Injectables: Side Effects
Many women experience no side effects. Possible side effects include:
Abdominal bloating and discomfort
Amenorrhea (no menses)
Headaches and dizziness
Illustration credit: Ambrose Hoona-Kab
Many women experience no side effects, but some users of injectables experience side effects.
The most commonly reported side effects of DMPA and NET-EN are menstrual changes, including prolonged, heavy or irregular bleeding, spotting, and amenorrhea.
In the first three to six months, women using progestin-only injectables commonly experience irregular bleeding or spotting and prolonged bleeding.
After one year, women commonly experience infrequent bleeding, irregular bleeding, and amenorrhea.
Less than 10% of DMPA users have normal cycles in the first year of use (90% of users will have bleeding changes in the first year).
Menstrual bleeding changes for any one client are unpredictable.
About 47 percent of women, nearly half, develop amenorrhea and have no monthly bleedings after one year of DMPA use
DMPA and NET-EN users also commonly report weight gain, although some injectables users report weight loss while others report no change in weight.
Less commonly reported side effects are headaches; dizziness; abdominal bloating and discomfort; mood changes, such as anxiety; and changes in sex drive. It is difficult to determine wither a change in a woman’s mood or reduced sex drive is related to DMPA or NET-EN or to other reasons; there is no evidence that injectables affect a woman’s sexual behavior.
Typically, nine out of ten of injectables users report at least one side effect during the first year of use. In most cases, none of these side effects result in health risks. Nonetheless, some side effects, such as changes in bleeding, may have serious practical and social consequences for women.
About one third of users discontinue in the first year due to side effects.
It is important to reassure clients that side effects are experienced by many women who use injectables and they are not signs of illness.
Weight gain
Changes in mood and sex drive
Prolonged or heavy bleeding irregular bleeding or spotting

17. Group Activity Injectables Fact Sheet
Review the fact sheet.
What additional questions or comments do you have about the characteristics of progestin-only injectables?
Introduce the fact sheet and ask participants to review the first page.
Ask participants if there are any additional comments or questions about the characteristics of implants.
Discuss and clarify as needed.
Ask participants to consider how they might be able to use the fact sheet in their work. Remind participants that although it might be useful for helping providers to remember important information to share with clients, the fact sheet is not intended to be used as a brochure to be distributed to clients.
Ask participants to review page two of the fact sheet. Inform the participants that the next segment of the training will address the issues outlined on page two of the fact sheet.