Mood disturbances during OC use
Conditions
Interventions
All participants will receive two tablets of study medication, which will be ingested daily during the first 21 days of every cycle. These tablets will either contain DHEA or placebo. During the pill-
Sponsors
Pantarhei Bioscience
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women using oral contraceptives for at least 3 months prior to screening and aged 20-35 years (inclusive) (for subgroup: 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). 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.
Exclusion criteria
Exclusion criteria: 1. Use of non-oral hormonal contraception in the 3 months prior to the screening (for subgroup: Use of oral hormonal contraception in the 3 months prior to the screening). 2. Intention to become pregnant during the study. 3. Lactation and/or pregnancy in the previous 6 months prior to screening. 4. Any clinically significant abnormality following review of medical and gynaecological history, clinical laboratory (haematology, biochemistry and androgen parameters) and physical examination and vital signs. 5. Contraindications for contraceptive steroids. 6. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to evaluate the effect of DHEA on mood disturbances during OC use | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess general effects on well-being - To assess satisfaction and health related quality of life | — |
Contacts
Public ContactF.J.M.E. Roumen
Atrium Medisch Centrum Parkstad P.O. Box 4446
Outcome results
None listed