|Appears in Collections:||Psychology Journal Articles|
|Peer Review Status:||Refereed|
|Title:||Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II Clinical effects|
Fauser, Bart C J M
Cobey, Kelly D
Coelingh Bennink, Herjan J T
|Citation:||Zimmerman Y, Foidart J, Pintiaux A, Minon J, Fauser BCJM, Cobey KD & Coelingh Bennink HJT (2015) Restoring testosterone levels by adding dehydroepiandrosterone to a drospirenone containing combined oral contraceptive: II Clinical effects. Contraception, 91 (2), pp. 134-142. https://doi.org/10.1016/j.contraception.2014.11.008|
|Abstract:||Objectives: Combined oral contraceptives (COCs) decrease androgen levels, including testosterone (T), which may be associated with sexual dysfunction and mood complaints in some women. We have shown that co-administration of dehydroepiandrosterone (DHEA) to a drospirenone (DRSP) containing COC restored total T levels to baseline and free T levels by 47%. Here we describe the effects on sexual function, mood and quality of life of such an intervention. Study design: This was a randomized, double-blind, placebo-controlled study in 99 healthy COC starters. A COC containing 30 μg ethinylestradiol (EE) and 3 mg DRSP was used for 3 cycles, followed by 6 cycles of the same COC combined with 50 mg/day DHEA or placebo. Subjects completed the Moos Menstrual Distress Questionnaire (MDQ), the McCoy Female Sexuality Questionnaire (MFSQ) and the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Safety and tolerability, including effects on skin were evaluated. Results: The addition of DHEA induced small, but significant improvements compared to placebo in the MDQ score for: Autonomic reactions during the menstrual (- 2.0 vs 0.71; P = 0.05) and the pre-menstrual phase (- 3.1 vs 2.9; P = 0.01); and for Behavior during the inter-menstrual phase (- 1.4 vs 3.6; P = 0.02). A significant difference was found in the MDQ score for arousal during the pre-menstrual phase in favor of placebo (- 5.0 vs 1.0; P = 0.01). There were no statistically significant differences between groups for the MSFQ and Q-LES-Q scores. DHEA co-administration resulted in an acceptable safety profile. DHEA negated the beneficial effect of the COC on acne according to the subjects' self-assessment. Conclusions: Co-administration with DHEA did not result in consistent improvements in sexual function, mood and quality of life indicators in women taking EE/DRSP. Retrospectively, the 50 mg dose of DHEA may be too low for this COC. Implications: A well-balanced judgment of the clinical consequences of normalizing androgens during COC use may require complete normalization of free T.|
|Rights:||Published in Contraception by Elsevier; Elsevier believes that individual authors should be able to distribute their AAMs for their personal voluntary needs and interests, e.g. posting to their websites or their institution’s repository, e-mailing to colleagues. However, our policies differ regarding the systematic aggregation or distribution of AAMs to ensure the sustainability of the journals to which AAMs are submitted. Therefore, deposit in, or posting to, subject-oriented or centralized repositories (such as PubMed Central), or institutional repositories with systematic posting mandates is permitted only under specific agreements between Elsevier and the repository, agency or institution, and only consistent with the publisher’s policies concerning such repositories. Voluntary posting of AAMs in the arXiv subject repository is permitted.|
|clinical.pdf||Fulltext - Accepted Version||675.23 kB||Adobe PDF||View/Open|
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