Use of Norethindrone Acetate for Management of Bleeding Associated With the Etonogestrel Contraceptive Implant

Conditions

• Etonogestrel Contraceptive Implant, Bothersome Bleeding

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Norethindrone acetate — DRUG

Study Details

The overall objective of this study is to confirm that oral progesterone is an effective way to manage bothersome bleeding; thus increasing the rate of continuation of the etonogestrel contraceptive implant in adolescents.

Key Dates

Start date

Aug 31, 2015

Status verified

Feb 2022

Primary completion

Jun 29, 2017

Completion

Jun 29, 2017

Study Design

Enrollment

88 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Norethindrone acetate (aygestin)
  Norethindrone acetate (aygestin) will be used to manage bothersome bleeding. Patients will be prescribed aygestin 5 mg by mouth twice daily for one month, followed by aygestin 5 mg by mouth once daily for two months. Medication will then be discontinued. Patients will be evaluated in the office three months after medication initiation, and then again six months after medication initiation. If the patient is unable to take norethindrone acetate (aygestin) due to medical contraindications or cost, they will receive medroxyprogesterone acetate (provera) 10 mg once daily as alternate oral progesterone. Figure 1 below highlights the study

Primary Outcome Measure

Impact of Aygestin (and Dose of Aygestin) on the Management of Bothersome Bleeding Associated With the Etonogestrel Contraceptive Implant [ Time Frame: Initial 3 months of baseline collection (medicine free); For intervention group, 3 months of medicine, followed by 3 months of medicine free; For control group, 6 months of medicine free. ]

Locations (1)

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