| Eligibility |
Inclusion Criteria:
1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy
aged between 13-45 years (inclusive) (at the time of trial enrollment).
Female subjects at risk of pregnancy aged between 13 and 17 years (inclusive) provided
that:
1. Applicable national, state and local laws allow subjects in this age group to
consent/assent to receive contraceptive services,
2. All applicable laws and regulations regarding the informed consent/assent of the
subjects to participate in clinical trials are observed.
2. Women who:
1. have never used hormonal contraceptives before consent/assent (naïve users),
2. have used hormonal contraceptives in the past, but have had a hormonal
contraceptive-free period before consent/assent and a full menstrual cycle during
the drug-free period (previous users)
3. directly switch from another hormonal contraceptive (switchers).
3. Only for subjects who did not use hormonal contraception during the last six months
before consent/assent: Regular cycles (i.e. cycle length between 24 and 35 days)
during the last six months.
4. At least three complete menstrual cycles after delivery pregnancy (only applicable for
women who were pregnant within the last six months).
5. At screening, maximum systolic blood pressure = 140 mm Hg and diastolic blood pressure
= 90 mm Hg.
6. Be able and willing to provide written informed consent or assent if the subject is
adolescent, prior to undergoing any trial-related procedure.
7. Willing to use trial contraception for thirteen 28-day cycles.
8. Be willing to have intercourse in each cycle of the trial without the need to use
back-up contraceptive.
9. Be willing to state that, to her best knowledge, her male sexual partner(s):
1. Has not had a vasectomy or been previously diagnosed as infertile.
2. Has not been previously diagnosed or suspected of human immunodeficiency virus
(HIV) unless he has subsequently had a negative HIV test.
3. Has not been known to have engaged in homosexual intercourse in the past five
years unless he has had negative HIV test results since then.
4. Has not shared injection drug needles in the past unless he has had a negative
HIV test at least six weeks since last use.
10. Agree not to participate in any other clinical trials during the course of this trial
(participation in a non-interventional study is allowed).
Exclusion Criteria:
1. Pregnancy, wish for pregnancy, or breastfeeding subjects.
2. Subject is known to or suspected of not being able to comply with the trial protocol,
the use of the trial medication or the use of the trial diary.
3. History of infertility.
4. Abnormal finding on pelvic, breast or ultrasound examination that in the
investigator's opinion contraindicates participation in the trial.
5. Unexplained amenorrhea.
6. Known polycystic ovary syndrome (PCOS).
7. Women =21 years of age with a Papanicolaou (pap) smear reading low-grade squamous
intraepithelial lesion (LGSIL) or higher at screening (or six months prior to
screening date). Subjects with atypical squamous cells of undetermined significance
(ASC-US) can be included if they are negative for high-risk human papilloma virus
(HPV) strains. Subjects <21 years of age do not require a pap smear.
8. Known contraindication or hypersensitivity to ingredients or excipients of the IMP,
including:
1. Presence or risk of a venous thromboembolism (VTE)
2. Venous thromboembolism - existing VTE (even under treatment with anticoagulants)
or history of VTE* (e.g., deep venous thrombosis [DVT] or pulmonary embolism
[PE])
*including a positive family history (VTE ever in a sibling or parent in
particular at an age before 50 years)
3. Known hereditary or acquired predisposition for VTE, e.g., activated protein C
(APC) resistance (including Factor V Leiden), antithrombin III deficiency,
protein C deficiency, protein S deficiency, or prothrombin-related thrombophilia
4. Major surgery with prolonged periods of immobilization
5. High risk of venous thromboembolism due to the presence of multiple risk factors
6. Presence or risk of an arterial thromboembolism (ATE)
7. Arterial thromboembolism - existing ATE, history of ATE (e.g., myocardial
infarction) or prodromal condition (e.g., angina pectoris)
8. Cerebrovascular disease - existing stroke, stroke or prodromal disorder (e.g.,
history of transient ischemic attack [TIA])
9. Known hereditary or acquired predisposition for ATE, e.g., hyperhomocysteinemia
and antiphospholipid antibodies (anticardiolipin antibodies, lupus
anticoagulants)
10. History of migraine with focal neurological symptoms
11. High risk of arterial thromboembolism due to multiple risk factors or to the
presence of one serious risk factor such as diabetes mellitus with vascular
damage, severe hypertension, severe dyslipoproteinemia, smokers or existing or
previous pancreatitis, if it is associated with severe hypertriglyceridemia
12. Existing or previous liver diseases in which liver function has not returned to
normal (also Dubin-Johnson and Rotor syndrome)
13. Existing or previous liver tumors
14. Known or suspected sex hormone-dependent malignant tumors (e.g., breast or
endometrium)
15. Unexplained vaginal bleeding
16. Hypersensitivity to the active ingredients or any of the excipients
17. Concomitant use with the medicinal products containing ombitasvir/paritaprevir/
ritonavir and dasabuvir.
9. Uncontrolled thyroid disorder (i.e., on stable dose of thyroid replacement for less
than two months at the time of assent/consent).
10. Uncontrolled concomitant diseases (i.e., not on a stable treatment dose for at least
two months at the time of assent/consent).
11. Evidence or history of alcohol, medication or drug abuse (within the last 12 months
prior to consent/assent) or medication abuse (within the last three months prior to
consent/assent).
12. Predisposition bruising within the last 12 months prior to consent/assent.
13. Known or suspected HIV, hepatitis and/or HPV infection (if the infection is due to
aggressive strains) at screening.
14. Less than 3 menses after discontinuing dosing of depot medroxyprogesterone acetate
(DMPA or Depo-Provera®) or any combined injectable contraceptive (e.g., Cyclofem®)
prior to consent/assent.
15. Long-term treatment (longer than seven consecutive days within a month prior to V1b)
of any medication that might interfere with the efficacy of hormonal contraceptives,
e.g.:
1. Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate,
felbamate)
2. Barbiturates (e.g. primidone)
3. Some antibiotics (such as rifampicin)
4. HIV medication (such as ritonavir, neviparine and efavirenz)
5. Bosentan
6. Griseofulvin
7. St. John's wort (hypericum perforatum)
8. Metoclopramide
16. Prohibited medication including the regular intake or use of estrogens, progestogens,
activated charcoal, microsomal enzyme-inducing drugs
17. Administration of human chorionic gonadotropin (hCG) or intake of co-medication
containing hCG within a month prior to V1b).
18. Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in
place within the last two months prior to consent/assent.
19. Planned regular concomitant use of barrier contraceptive methods, spermicides, IUDs or
other contraceptive measures (except occasional use for safety reasons, e.g., to
reduce risk of infection).
20. Evidence or history of clinically significant psychiatric illness, such as major
depression or schizophrenia, that in the investigator's opinion contraindicates
participation in the trialor suicide risk.
21. Planned surgery during the anticipated time of participation in this trial requiring
withdrawal of an oral contraceptive.
22. Participation in another trial of an investigational drug or device parallel to the
current trial or less than 90 days before consent/assent, or previous participation in
the current trial and dispensed trial medication.
23. Subject is a member of the investigator's or sponsor's staff or a relative or family
member thereof.
24. Any condition that, in the opinion of the investigator, may jeopardize protocol
compliance or the scientific integrity of the trial.
25. Severe COVID-10 disease or less than 3 months after hospitalization due to a COVID-19
disease.
|
