Intervention: Zoely
Trial phase: Phase 3
SMILES: CC(=O)OC1(C(C)=O)CCC2C3C=C(C)C4=CC(=O)CCC4C3CCC21C.CC12CCC3c4ccc(O)cc4CCC3C1CCC2O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 56
Group description: Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
Eligibility criteria:
Inclusion criteria:

Sexually active women, at risk for pregnancy and not planning to use condoms

during treatment;

At least 20 but not older than 35 years of age at the time of screening;
BMI = 17 and = 35;
Good physical and mental health;
Willing to give informed consent in writing;
Willing to take part in the trial for two years.

Exclusion criteria:

Family history of osteoporotic fracture below the age of 70;
Postgastrectomy;
History of eating disorder, viz. anorexia nervosa, bulimia;
Endocrine disorder (including controlled diabetes, [para]thyroid disease, Cushing's disease);
Rheumatoid arthritis;
Significant scoliosis;
Fasting parathyroid hormone (PTH) outside the reference range at screening;
Fasting calcitonin outside the reference range at screening;
Prolactin above the reference range (hyperprolactinemia) at screening;
Fasting cholesterol and/or triglycerides above the reference range for age at screening (treatment with lipid lowering drugs not allowed);
Engaging in vigorous exercise such as marathon, competitive swimming, triathlon;
Smoking more than ten cigarettes/day;
Use of more than two units of alcohol a day;

Use of one or more of the following drugs:

gonadotropin releasing hormone (GnRH) analogues (also past use for more than six months at any time, or for any period of time less than six months ago is a contraindication);
systemic or inhaled administration of corticosteroids (also past use for more than one year, less than five years ago or any period of time in the past year is a contraindication);
thiazide diuretics;
thyroid hormone;
bisphosphonates;
calcium supplementation in combination with vitamin D supplementation/

calcitonin;

ever treatment after childhood with fluorides;

Contraindications for contraceptive steroids
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia[CIN], squamous intraepithelial lesion [SIL], carcinoma in situ, invasive carcinoma) at screening;
Clinically relevant abnormal laboratory result at screening as judged by the investigator;
Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
Within 12 months after a pregnancy prior to the start of trial medication;
Breastfeeding or within 12 months after stopping breastfeeding prior to the start of trial medication;
Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post-treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort);
Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.