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Clinical Trials/ISRCTN62695528
ISRCTN62695528
Active, not recruiting
Phase 3

A Phase III, open-label, multicenter study to evaluate contraceptive efficacy and safety of depot medroxyprogesterone acetate (150 mg/ml) injected subcutaneously every 6 months

Family Health International 3600 sites750 target enrollmentMay 26, 2022
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ConditionsContraception for up to 6 monthsPregnancy and Childbirth

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Contraception for up to 6 months
Sponsor
Family Health International 360
Enrollment
750
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 26, 2022
End Date
January 15, 2026
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Family Health International 360

Eligibility Criteria

Inclusion Criteria

  • •Current inclusion criteria as of 22/12/2023:
  • •Women may be included in the study if they meet all of the following criteria:
  • •1\. In good general health as determined by medical history, physical and gynecological exams
  • •2\. Aged 18\-35 years at treatment initiation, inclusive
  • •3\. Willing to provide informed consent, follow all study requirements and rely on 6\-month DMPA SC as the only means of contraception for 12 months (i.e., two injections 6 months apart)
  • •4\. At risk of pregnancy (in a heterosexual relationship, no diagnosis of infertility, no history of tubal ligation or hysterectomy, primary partner is not vasectomized or otherwise sterile, and an average of one or more acts of vaginal intercourse per month)
  • •5\. Not pregnant and has no desire to become pregnant for at least the next 12 months
  • •6\. Regular (21\-35 days) menstrual cycle (when not using hormonal contraceptives)
  • •7\. At least two normal menses since the last injection of any injectable contraceptive (if not using other hormonal contraceptives)
  • •8\. Hemoglobin \=9\.5 g/dl

Exclusion Criteria

  • •Current exclusion criteria as of 22/12/2023:
  • •Women will be excluded from participating in this study if they meet or have one or more of the following criteria:
  • •1\. Lactating
  • •2\. Hypertension with systolic BP \=160 mm Hg or diastolic BP \=100 mm Hg
  • •3\. Multiple risk factors for cardiovascular disease (eg, smoking, obesity,diabetes, hypertension and known dyslipidemias)
  • •4\. Current and/or history of deep venous thrombosis (DVT)/pulmonary embolism (PE)
  • •5\. Current and/or history of arterial thrombotic or thromboembolic events (ATE) (ie, myocardial infarction, ischaemic heart disease, stroke, or peripheral arterial disease)
  • •6\. Systemic lupus erythematosus
  • •7\. Migraine with aura
  • •8\. Unexplained vaginal bleeding

Outcomes

Primary Outcomes

Not specified

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