N/A Completed N=35 Treatment

The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception

Pregnancy · HIV · AIDS

Source: ClinicalTrials.gov NCT01667978 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2015

Primary outcomePrimary: AUC Norethindrone — 37.81; 25.21 ng*h/mL — p=<0.05

Summary

The purpose of this study is to learn if women taking the atazanavir and ritonavir have lower levels of a birth control medication called norethindrone. Norethindrone (also called the mini pill) is an FDA (Food and Drug Administration) approved progestin-only birth control pill used to prevent pregnancy. Norethindrone is the standard medication used in women who take the progestin only pill to prevent pregnancy. There are other birth control pills which contain different medications. The investigators want to learn if HIV medications (atazanavir and ritonavir) make the blood level of this birth control pill higher or lower. If the levels of norethindrone are too low it may not work to prevent pregnancy. The investigators also hope to learn about changes in the vaginal fluids and cervical fluids when women are taking this birth control pill.

Outcome Measures

Outcome	Result	p-value
PRIMARY AUC Norethindrone	37.81; 25.21	<0.05 sig

Eligibility Criteria

Inclusion Criteria

Ages: 18-44 years Gender: female Accepts: healthy volunteers and HIV-1 infected women Acceptable medications include: no other medications, NRTI combinations, entry inhibitors, integrase inhibitors, and CCR5 agonists. NRTI combinations may include but are not limited to: zidovudine (ZDV), lamivudine (3TC), emtricitabine (FTC), didanosine (ddl), stavudine (d4T), abacavir (ABC), and tenofovir disoproxil fumarate (TDF). NNRTI: etravirine, and rilpivirine.

Exclusion criteria

History of bilateral oophorectomy, ovarian dysfunction or no regular periods. CD4+ cell count <200 cells/mm3 No current or uncontrolled thyroid, liver, or renal disease BMI <40 kg/m^2 Current pregnancy, breastfeeding or pregnancy within 30 days of enrollment. Depomedroxyprogesterone acetate injection (DMPA) within 180 days prior to study entry.

Other hormonal therapies (e.g. oral contraceptive agents, Provera, vaginal ring, contraceptive patch, monthly contraceptive injection, hormone replacement therapy, anabolic therapies, including nandrolone decanoate or megestrol acetate) within the 21 days prior to study entry.

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Data sourced from ClinicalTrials.gov (NCT01667978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.