Intervention: LEVONORGESTREL
Trial phase: Phase 3
ATC code: G03AA07 | G03AB03 | G03AC03 | G03AD01 | G03FA11 | G03FB09
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3([H])[C@@]1([H])CC[C@@]1(CC)[C@@]2([H])CC[C@@]1(O)C#C
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 72
Group description: Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
Eligibility criteria:
Inclusion Criteria:

Each woman enrolled in the trial must meet the following inclusion criteria:

Competent to provide informed consent to participate in the trial and has done so.
At least the minimum age is 18 to 45 years old.
Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months.

At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following:

More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months
Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma
Sharing of illicit injection drug equipment ever in the past.
Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs).
Wants to avoid pregnancy for at least the next 6.5 months.
Willing to accept an uncertain risk of pregnancy during the study.
Gives correct answers to the informed consent quiz.
Willing and able to follow all study requirements.

Exclusion Criteria:

To be eligible for enrollment, a woman must not meet any of the following exclusion criteria:

Pregnant as verified by a pregnancy test at enrollment.

Has an indication of current subfecundity, specifically:

Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy
She has not had normal monthly menses for the past 2 months
She is currently breastfeeding
She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period
Has received an injection of a long term injectable contraceptive in the last 9 months
Currently has an intrauterine device
Has had a sterilization procedure or ectopic pregnancy
Has been diagnosed by a clinician as having a fertility problem
Her partner has had a sterilization procedure or infertility diagnosis, to her knowledge.

She currently has known contraindications to progestin-only pills, specifically including the following conditions:

Unexplained abnormal vaginal bleeding
Deep venous thrombosis or pulmonary embolus
Active viral hepatitis
Decompensated cirrhosis
Liver tumor
History of breast cancer within the past 5 years.
Has a breast mass on examination.
Has a personal or family history suggestive of predisposition to thrombosis.
Has a serious contraindication to pregnancy (medical condition or use of chronic medication such as isotretinoin or thalidomide).
Taking drugs that are known to interact with progestins (such as rifampicin or anticonvulsant medications).
Has previously participated in this study.
Currently participating in another medical research study.
The site investigator or designee perceives another reason to exclude her from the trial.