Biochemical disturbances (androgens, lipids, bone markers, endocrine) and mood distrubances caused by the use of Oral Contraception (OC).
Conditions
Interventions
Product Name: dehydroepiandrosterone (DHEA)
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Yasmin
Product Code: G0
Sponsors
Pantarhei Bioscience BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women using oral contraceptives for at least 3 months prior to screening and aged 20-35 years (inclusive) 2. Report of mood disturbances, and attributing this to OC use as evidenced by in depth interview independently performed by two investigators 3. Regular menstrual cycles (24-35 days) prior to last start of OC use 4. Body mass index between (=) 18 and (=) 35 kg/m2 5. Good physical and mental health as judged by the Investigator determined by medical and gynaecological history, physical examination, clinical laboratory and vital signs 6. Willing to give informed consent in writing For the subgroup, inclusion criterion 1 is not applicable and will be adapted to: 1. Women, aged 20-40 years (inclusive), using a non-hormonal contraceptive method for at least 3 months and willing to use an OC for 6 subsequent cycles Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Androgen therapy during the 6 months prior to screening 2. Use of non-oral hormonal contraception in the 3 months prior to the screening 3. Use of injectable contraceptives (e.g. cyclofem or DMPA) during the 6 months prior to the screening 4. Use within the past 3 months of implanted hormonal contraceptives Mirena® (progestin containing IUD) and Implanon® (subdermal implant delivering etonogestrel) 5. Intention to become pregnant during the study 6. Lactation and/or pregnancy in the previous 6 months prior to screening 7. History of/or current psychiatric disorder which is not related to the use of an OC 8. Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication prior to screening 9. Any clinically significant abnormality following review of medical and gynaecological history, clinical laboratory (haematology, biochemistry and androgen parameters) and physical examination and vital signs 10. Contraindications for contraceptive steroids: - A history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder - A history of, or existing conditions predisposing to, or being prodromi of, a thrombosis - A known defect in the blood coagulation system (e.g. deficiencies in AT-III, protein C, S, APC resistance and Factor V Leiden mutation) - The presence of more than one risk factor for vascular disease (e.g. dyslipoproteinemia; diabetes mellitus; hyperhomocysteinemia; systemic lupus erythematosus; chronic inflammatory bowel disease; antiphospholipid antibodies; smoking; venous thromboembolism in sibling or parent below (<) the age of 50, or arterial disease in sibling or parent below (<) the age of 35; within 2 weeks after full remobilization following surgery) - Hypertension, i.e. systolic blood pressure ? 140 mmHg and/or diastolic blood pressure ? 90 mmHg - Disturbance of liver function: cholestatic jaundice, a history of jaundice of pregnancy or jaundice due to previous estrogen use, Rotor syndrome and Dubin-Johnson syndrome - Known or suspected estrogen-dependent tumors or endometrial hyperplasia - Undiagnosed vaginal bleeding - Porphyria - A history during pregnancy or previous estrogen-use of severe pruritus, herpes gestationis or deterioration of otosclerosis 11. Use of one or more of the following medications: - Psychoactive drugs - Antihypertensive drugs - Sex steroids other than the current OC - Use at present or within 30 days before start study medication: hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin, nelfinavir, ritonavir and St. John’s wort (Hypericum perforatum) 12. Administration of any investigational drug within 3 months prior to screening For the subgroup, exclusion criterion 2 is not applicable and will be adapted to: 2. Use of oral hormonal contraception in the 3 months prior to the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of concomitant treatment with dehydroepiandrosterone (50 mg) on mood in women who experience mood disturbances during oral contraception-use.;Secondary Objective: To assess the general effects on well-being; To assess satisfaction and health related quality of life. ;Primary end point(s): Daily mood rating (1-5) General effect of study medication on subject’s well-being over the past 3 weeks Satisfaction and health related quality of life over de past week of OC intake | — |
Countries
Netherlands
Outcome results
None listed