WARNING: LOSS OF BONE MINERAL DENSITY
Women who use medroxyprogesterone acetate injectable suspension may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.
It is unknown if use of medroxyprogesterone acetate injectable suspension during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.
Medroxyprogesterone acetate injectable suspension should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate [see
Warnings and Precautions (5.1)].
|
|
SUMMARY
Medroxyprogesterone Acetate Injectable Suspension, USP, a contraceptive injection, contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone Acetate Injectable Suspension, USP is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder that is stable in air and that melts between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.
Medroxyprogesterone Acetate Injectable Suspension, USP is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone Acetate Injectable Suspension, USP long-term [ see
Warnings and Precautions (5.1) ].
|
|
NEWS HIGHLIGHTS
Published Studies Related to Medroxyprogesterone
Elagolix, an oral GnRH antagonist, versus subcutaneous depot medroxyprogesterone
acetate for the treatment of endometriosis: effects on bone mineral density. [2014] This randomized double-blind study, with 24-week treatment and 24-week
posttreatment periods, evaluated the effects of elagolix (150 mg every day, 75 mg
twice a day) versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC) on
bone mineral density (BMD), in women with endometriosis-associated pain (n =
252)...
A four week randomised control trial of adjunctive medroxyprogesterone and
tamoxifen in women with mania. [2014] Emerging research has suggested that hormone treatments such as selective
oestrogen receptor modulators (SERMs) or progestins may be useful in the
treatment of mania. The current pilot study compared the use of the SERM
tamoxifen and the progestin medroxyprogesterone acetate (MPA), as an adjunct to
mood stabiliser medications, for the treatment of mania symptoms in 51 women in a
28-day double blind, placebo controlled study...
Differential effects of estrogen and micronized progesterone or medroxyprogesterone acetate on cognition in postmenopausal women. [2011.08] OBJECTIVE: To investigate possible differential effects of the coadministration of conjugated equine estrogen (CEE) and a placebo (CEE + PL), CEE and medroxyprogesterone acetate (CEE + MPA), or CEE and micronized P (CEE + MP) on aspects of cognitive functioning in naturally postmenopausal women...
Effects of percutaneous estradiol-oral progesterone versus oral conjugated equine estrogens-medroxyprogesterone acetate on breast cell proliferation and bcl-2 protein in healthy women. [2011.03.01] In a prospective, randomized clinical study 77 women were assigned randomly to receive sequential hormone therapy with either conventional oral conjugated equine estrogens (0.625 mg) with the addition on 14 of the 28 days of oral medroxyprogesterone acetate (5 mg) or natural E(2) gel (1.5 mg) with oral micronized P (200 mg) on 14 of the 28 days of each cycle.
Differential effects of estrogen and micronized progesterone or
medroxyprogesterone acetate on cognition in postmenopausal women. [2011] OBJECTIVE: To investigate possible differential effects of the coadministration
of conjugated equine estrogen (CEE) and a placebo (CEE + PL), CEE and
medroxyprogesterone acetate (CEE + MPA), or CEE and micronized P (CEE + MP) on
aspects of cognitive functioning in naturally postmenopausal women... These findings need to be
replicated with a larger sample size before their potential clinical implications
can be determined.
Clinical Trials Related to Medroxyprogesterone
Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation [Completed]
Many women choose Depo-Provera for birth control because it is easy to use and very
effective. However, a significant number of Depo-Provera users experience irregular bleeding
during the first 90 days. Many users discontinue after their first injection due to
irregular bleeding. This study will evaluate the effect of using an estrogen vaginal ring
during the first 90 days of Depo-Provera use to see if it is acceptable to women and whether
it decreases irregular bleeding during the first 90 days of use and increases continuation
to a second injection.
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression [Recruiting]
In the United States, depot medroxyprogesterone acetate (DMPA) is given to women after
delivery and before hospital discharge with the belief that women who delay starting DMPA
may be more likely to become pregnant when they are not yet ready to be pregnant and that
giving DMPA before discharge has little to no negative effect on breastfeeding.
Administering DMPA to breastfeeding women has not been widely questioned because the limited
existing studies do not show any adverse impact of DMPA on breastfeeding. However, these
studies used inappropriate control groups and did not control for prior lactation
experience.
The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after
delivery to find out whether the timing of postpartum administration of DMPA (prior to
hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of
breastfeeding among women who plan to breastfeed their infants. The investigators will also
look at rates of use of highly effective contraception (defined as DMPA, intrauterine
device, implant, sterilization, or lactational amenorrhea) and postpartum depression.
Pharmacokinetic Interactions Between DMPA and LPV/Rit Among HIV-Infected Women [Completed]
This study is being done to look at the level of Depo-Provera, an injectable birth control,
in the blood to see whether it is affected by the anti-HIV drug Kaletra (lopinavir/ritonavir
[LPV/r]). It is not known whether taking Depo-Provera together with Kaletra changes the
amount of Kaletra in blood. Therefore, this study will also look at the levels of HIV and
Kaletra before and after receiving a shot of Depo-Provera. This study will take a look at
the safety of Depo-Provera and Kaletra when they are used together. In addition to what is
stated above, this study will also explore any effect of Depo-Provera on the immune system.
Medroxyprogesterone +/- Cyclophosphamide & Methotrexate in Hormone Receptor-Negative Recurrent/Metastatic Breast Cancer [Completed]
The purpose of this study is to evaluate the impact of MPA alone and in combination with low
dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.
Study of Self or Clinic Administration of DepoProvera [Completed]
Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for
many women. However, difficulty in access may cause many women to discontinue use, often
without the use of another effective method of contraception, thereby leaving them
vulnerable to unintended pregnancy. This study will randomly assign women who present for
contraceptive services to two groups: self or clinic administered SC DMPA. The participants
will be followed for one year to compare continuation rates, acceptability, cost
effectiveness, evidence of skin changes, and need for continued support between the two
groups.
Reports of Suspected Medroxyprogesterone Side Effects
Depression (8),
Nausea (8),
Breast Cancer (7),
Dizziness (6),
Irritability (6),
Agitation (5),
Disorientation (5),
Somnolence (5),
DRY Mouth (5),
Nervousness (5), more >>
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Medroxyprogesterone has an overall score of 6. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| Medroxyprogesterone review by 54 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Considerably Effective |
Side effects: | | Mild Side Effects | | Treatment Info |
Condition / reason: | | heavy periods, thickened endometrium |
Dosage & duration: | | 10mg daily days 15-27 of my cycle taken daily for the period of 18 months |
Other conditions: | | hypothyroidism |
Other drugs taken: | | levothyroxine | | Reported Results |
Benefits: | | Periods were not so heavy |
Side effects: | | constipation, low grade upset stomach |
Comments: | | daily dose of medication on days 15-27 of my cycle.
Periods were not as heavy but I did have breakthrough bleeding mid cycle which would last some months 7 days meaning I would flow for about 14 out of evey 27 days. Doctors could not give an explaination.
Am currently on natural progesterone in vaginal cream form - 1gm nightly days 10-15. This is my first month so it's too early to evaluate.
I switched becasue I did not want to continue with the oral - I have concerns about long term side effects. |
|
|
Page last updated: 2015-08-10
|