| Methods |
15 sites in China.
12 treatment months. |
| Participants |
Healthy women age 18 to 35 years with regular menses and proven fertility.
Excluded lactation; pregnancy; diabetes; abnormal Pap smears; unexplained vaginal bleeding; hypertension; liver disease; hypertension; thromboembolism; malignancy; abnormal nipple discharge; selected drug use; recent injectable or oral contraceptive. |
| Interventions |
Norethisterone enanthate 50 mg and estradiol valerate 5 mg (N=1960) versus medroxyprogesterone acetate 25 mg and estradiol cypionate 5 mg (N=1955).
Also included a study arm with Injectable No. 1, which was not included in the present review since the drug regimen was changed during the trial due to unacceptable efficacy rates. |
| Outcomes |
Contraceptive efficacy, discontinuation, weight, blood pressure, side effects. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization using random numbers table. |
| Allocation concealment (selection bias) |
Unclear risk |
No information |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
No information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
353 women in the norethisterone enanthate and 498 women in the medroxyprogesterone acetate group discontinued early. Primary reasons for discontinuation described; 10 women in the norethisterone enanthate and 14 women in the medroxyprogesterone acetate group cited weight gain.
17 women in the norethisterone enanthate and 18 women in the medroxyprogesterone acetate group were lost to follow up. |
