Pilot study: absorption and efficacy of multiple hormones delivered in a single cream applied to the mucous membranes of the labia and vagina.
OBJECTIVE
There is a lack of evidence in the literature supporting vaginal application of a combination hormone-containing cream for local and systemic symptom relief. This pilot study examined the extent of absorption of a single cream containing estriol, estradiol, progesterone, DHEA, and testosterone.


METHODS
A combination cream was administered to 12 postmenopausal women in two differing doses over two independent time periods. Following 28 days (arm 1) and an additional 14 days (arm 2), measurement of hormones in saliva and blood and measurements of symptom relief, patient tolerability, and health-related quality of life (HRQoL) were obtained.


RESULTS
The dosage and time of evaluation for study arm 1 was not ideal for providing documented increases in hormone levels. HRQoL measurements supported measured improvement in this arm. The second arm did document absorption of the various hormones when given vaginally.


CONCLUSIONS
This study is the first documenting systemic absorption of multiple hormones by both saliva and blood as well as improvement of HRQoL. This therapy was generally well-tolerated with only 2 patients experiencing minor irritation, not necessitating discontinuation. Additional studies in larger numbers of patients will provide better knowledge for clinicians wanting to provide similar therapy at the lowest effective dose.
Glaser
Rebecca L
RL
Millennium Wellness Center, Dayton, Ohio 45459, USA. rglaser@woh.rr.com
Zava
David T
DT
Wurtzbacher
Doug
D
D000282:Administration, Intravaginal; D000327:Adsorption; D000368:Aged; D003687:Dehydroepiandrosterone / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D004643:Emollients / Q000008:administration & dosage / Q000493:pharmacokinetics; D004958:Estradiol / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D004964:Estriol / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D005260:Female; D012739:Gonadal Steroid Hormones / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D009092:Mucous Membrane / Q000378:metabolism*; D010865:Pilot Projects; D011788:Quality of Life; D012463:Saliva / Q000378:metabolism; D013739:Testosterone / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D014621:Vagina / Q000378:metabolism*
D004643:Emollients; D012739:Gonadal Steroid Hormones; D013739:Testosterone; D003687:Dehydroepiandrosterone; D004958:Estradiol; D004964:Estriol