What can women expect with Depo-Provera®?
To help manage their expectations, there are several important things to know.

Assessment of women prior to starting hormonal contraceptives (and at regular intervals thereafter) should include an individual's personal and family medical history.

Women should be counselled that there is a potential for delay in return to ovulation following use of the method, regardless of the duration of use.^1*

Clinical trials studied the mean time to return to ovulation up to 15 months following the last dose of DMPA-IM:¹

*Repeat injections are required every 12 weeks (± 5 days) to maintain and ensure efficacy¹

After the first injection of Depo-Provera, it is likely that women will experience some changes to their menstrual cycle.¹

Amenorrhoea data were analysed from contraception studies of 1-year treatment with depot medroxyprogesterone acetate intramuscular (DMPA-IM)¹

Women should be advised that there is the potential for:¹

• Amenorrhoea
• Irregular bleeding and spotting
• Prolonged episodes of bleeding (> 10 days)^*
• Rarely, heavy prolonged bleeding.

If abnormal bleeding persists or is severe, appropriate investigation should take place to rule out the possibility of organic pathology and appropriate treatment should be instituted when necessary.

Weight change data were analysed from DMPA-IM contraception studies:¹

• Over first 1-2 years of use – average weight gain was 2.3-3.6 kg (5-8 lbs)
• Women completing 4-6 years of therapy – gained an average of 6.4-7.5kg (14-16.5lbs)
• There is evidence that weight is gained as a result of increased fat and is not secondary to an anabolic effect or fluid retention¹

Use of DMPA subcutaneous injection reduces serum estrogen levels and is associated with significant loss of BMD due to the known effect of estrogen deficiency on the bone remodelling system. Bone loss is greater with increasing duration of use, however BMD appears to increase after DMPA subcutaneous injection is discontinued and ovarian estrogen production increases.

This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of DMPA subcutaneous injection by younger women will reduce peak bone mass and increase the risk for fracture in later life.

A study to assess the BMD effects of DMPA-IM in adolescent females showed that its use was associated with a statistically significant decline in BMD from baseline. After discontinuing DMPA-IM in adolescents, return of mean BMD to baseline values required 1.2 years at the lumbar spine, 4.6 years at the total hip and 4.6 years at the femoral neck. However in some participants, BMD did not fully return to baseline during follow-up and the long-term outcome is not known in this group. In adolescents, Depo-Provera may be used, but only after other methods of contraception have been discussed with the patients and considered to be unsuitable or unacceptable.

A large observational study of predominantly adult female contraceptive users showed that use of DMPA-IM did not increase risk for bone fractures. Importantly, this study could not determine whether use of DMPA has an effect on fracture rate later in life.

In women of all ages, careful re-evaluation of the risks and benefits of treatment should be carried out in those who wish to continue use for more than 2 years. In particular, in women with significant lifestyle and/or medical risk factors for osteoporosis, other methods of contraception should be considered prior to use of Depo-Provera.

Significant risk factors for osteoporosis include:

• Alcohol abuse and/or tobacco use 

• Chronic use of drugs that can reduce bone mass

• Low body mass index or eating disorder

• Previous low trauma fracture

• Family history of osteoporosis

A long-term case-controlled surveillance of Depo-Provera users has shown that:¹

• Use of Depo-Provera does not increase risk of ovarian, liver, or cervical cancer.
• There was a prolonged, protective effect of reducing the risk of endometrial cancer with DMPA-IM users.

• Any excess risk in current or recent users is small in relation to the overall risk of breast cancer, particularly in young women
• The risk is not apparent after 10 years since last use
• Duration of use does not seem to be important.

Women should be counselled that Depo-Provera does not protect against STIs, including HIV infection and AIDS. Safer sex practices including correct and consistent use of condoms reduce the transmission of STIs through sexual contact. 

STIs: Sexually Transmitted Infections
HIV: Human Immunodeficiency Virus
AIDS: Acquired Immunodeficiency Syndrome

Patients with a history of endogenous depression should be carefully monitored. Some patients may complain of premenstrual-type depression while on Depo-Provera therapy.

Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.

As with any intramuscular injection, especially if not administered correctly, there is a risk of abscess formation at the site of injection, which may require medical and/or surgical intervention.

Should the patient experience pulmonary embolism, cerebrovascular disease or retinal thrombosis while receiving Depo-Provera, the drug should not be re-administered.

Reports of anaphylactic responses (anaphylactic reactions, anaphylactic shock, anaphylactoid reactions) have been received.

To read the full special warnings and precautions for use for Depo-Provera and see a full list of adverse events, refer to the Summary of Product Characteristics. The benefits of contraceptive options and their risks must be evaluated individually for each woman. If any of the conditions/risk factors mentioned is present, the benefits of Depo-Provera use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether Depo-Provera use should be discontinued.